Apply for Production Manager at Sanofi @ Apply Now

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.  With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Post : Production Manager

Job Description
• To manufacture a product that is compliant to SISPQ.
• To ensure GMP and GDP is followed at all levels of manufacturing and relevant activities.
• To coordinate with Projects and Engineering department during commissioning, qualification and maintenance activities.
• Responsible for organizing production schedule to meet the commitment to the supply chain department.
• To evaluate the Risk Analysis for equipment and processes.
• Supporting in managing the resources, planning and ensuring the coordination and control of formulation and filling department.
• To support Validation team to execute the validation and qualification activities as per the pre-approved protocols.
• To ensure the work place and equipment are maintained clean and hygienic all the time.
• To escalate the potential quality events to superiors and take part in investigations and root cause analysis.
• To initiate Change controls related to processes or process equipment pertaining to compounding area.
• To supervise Production operations and ensure the production plan is achieved with respect to quality, quantity, timelines, performance KPIs and HSE standards.
• To supervise, motivate and allow team personnel to develop his/ her competencies and potential in order to perform his/ her job better.
• To support and implement continuous improvements within his/her perimeter.

Duties & Responsibilities
Operations
• Responsible for Effective Operations of Equipment for compounding and filling area in Insulin facility.
• Ensure operations to be carried with budget planning and its effective utilization.
• To contribute in the definition and execution of the site strategy and is in-charge of implementing Operational Excellence standards (e.g: lean program).
• Supporting in fostering motivation and excellence in his perimeter.
• Responsible for timely support in execution and documentation of validations and other relevant activities.
• Responsible for preparation & Review of SOPs, batch production records and relevant documents pertaining to compounding & filling area.
• Act as a key point of contact for internal and external audit preparations.
• Act as an interface between manufacturing team and cross functional teams during investigations, change approvals, lean management and several miscellaneous activities.
• Improve the existing facility in terms of equipment and practices in compliance with site quality procedures.
• Define ways of working based on the goals and priorities.
• Ensure continuous improvement of Industrial performance in compounding and filling area.
• Simplify ways of working and establish low hierarchy.
• In-line with APU concept, take decisions in given boundaries to meet business requirements.

Training
• Train the staff on compounding operations as per Sanofi group strategy.
• Acquire relevant equipment and process training with respect to compounding and filling relevant operations.
• Prepare the team for various regulatory inspections/ audits and GMP compliance

Cross functional
• Responsible for co-ordinating with QA, QC, Validations, Engineering, HSE and Projects to support in respective relevant activities.
• Support activities conducted by cross functional departments such as HSE, Lean management and facilitate exchange of information.

HSE
• To identify, correct and promptly report unsafe conditions, behaviours, or potentially hazardous situations.
• To animate a strong, proactive culture oriented towards promoting positive behaviours at all times.
• To demonstrate visible commitment to HSE and have the special responsibility to lead by example

Candidate Profile
• Minimum of Bachelor’s/Masters degree in Pharmacy/M.Sc
• Minimum of 7 years’ experience.
• Pharmaceutical industry experience is a must.
• Act for change: Adapt to changing circumstances in positive and enthusiastic manner.
• Cooperate Transversally: Develop and maintain effective cross functional working relationships and partnerships.
• Develop people: Share best practices and expertise to improve team member’s competencies.
• Excellent communication skills.
• Capacity to imbibe new technologies.
• High levels of confidence and problem solving capabilities.
• Knowledge on GMP/ GXP and technicalities involved in manufacturing relevant activities.
• Language requirements: Fluency in English (reading, writing and listening).

Additional Information
Experience : 5+ years
Qualification :  M.Sc, B.Pharm, M.Pharm 
Location : Toopran Mandal, Telangana
Industry Type : Pharma
Functional Area : Production
End Date : 25th December, 2018

Require Junior Research Fellow at IIT - BHU @Apply now

Banaras Hindu University ranks among the first few in the country in the field of academic and research output. This university has two campuses, 3 institutes, 16 faculties, 140 departments, 4 advanced centers and 4 interdisciplinary schools. The University is making its mark at the national and international levels in a number of frontier areas of Science, Social Science, Technology, Medicine and Agriculture etc

Applications are invited from Indian nationals for the post of Junior Research Fellow (JRF) at a Fellowship of Rs 25000/ + 20% HRA / per month for 1st two years and Rs 28000/ + 20% HRA / per month for 3rd year in a DBT Twinning research project entitled “Phytochemical and pharmacological evaluations of bioactivity guided fractions of medicinal plants of Tripura”, sponsored by Department of Biotechnology, Government of India, New Delhi for a period of 3 years. The post is purely temporary and co-terminus with the project.

The candidates should have basic degree in pharmacy (B.Pharm.) and possess first class in M.Pharm. degree with qualified GATE/GPAT score. The upper age limit is 28 Years (relaxable for 5 years for SC/ST/Physically Handicapped/Female candidates). All things being equal, SC/ST candidates will be preferred as per GOI rules.

Essential qualifications: B.Pharm degree and GPAT/GATE with first class in M.Pharm. degree.

Desirable qualifications: One year industrial experience or research experience in the field of phytochemical investigation, standardization, biological activity and formulation development.

Interested candidates should send their applications strictly in the attached application format via email to Principal Investigator Dr. Alakh Niranjan Sahu at ansahu.phe@itbhu.ac.in on or before 20th December, 2018.

Please write “Application for JRF” in the subject line of the email. The shortlisted candidates will be intimated by email. Tentative date of interview: within two weeks of application deadline. No TA/DA will be paid if called for interview.

General Instructions:
1. The PI has the discretion to restrict the number of candidates to be called for interview to a reasonable limit on the basis of qualifications and experience higher than the minimum prescribed in the advertisement.
2. Only shortlisted candidates will be communicated to appear in the interview and no other communications in this regard will be entertained.
3. Original certificates and self-attested copies of all certificates need to be presented before the interview for verification.
4. Venue of Interview: Department of Pharmaceutical Engineering & Technology, IIT (BHU), Varanasi-221005. E-mail: ansahu.phe@itbhu.ac.in
5. Application should be strictly according to the attached format.
6. Last date for receiving completed application is 20th December, 2018.

Alakh Niranjan Sahu
Principal Investigator
Department of Pharmaceutical Engineering & Technology
IIT (BHU), Varanasi-221005
Email: ansahu.phe@itbhu.ac.in

Apply for Regulatory Affairs Specialist at Medtronic @Click here for more details

Post : Regulatory Affairs Specialist

Job Description
• Manage, plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations and renewals) thereby supporting the business units and supply chain management in compliance with regulatory requirements in the Indian Sub-Continent (India, Sri Lanka, Bangladesh, Nepal)
• Coordination with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in Indian Sub-Continent.
• Submit and track registration/re-registration applications with the authorities.
• Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.
• Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance (reporting of adverse events/field actions, etc.).
• Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance.
• Close monitoring of any changes in local & global regulations and communicating same within the department and respecting & following all SOP / system implemented within the department and organization.
• Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance.  Also ensure continuous implementation of the Quality Management System in India.
• Supporting the Marketing Teams on Tender related issues
• Interface and coordinate with regulatory agencies/competent authorities (CDSCO, CDDA, DGDA, State FDA, DoT, AERB, etc.) with respect to submissions, obtaining registrations/licenses, amendments, regulatory compliance, packaging, quality control testing or release, etc.
• Work with clinical team on submission and approval of clinical trials applications (clinical trial approvals, import licenses/test licenses for clinical trial, amendments, etc.) from various regulatory agencies in the Indian Sub-Continent
• Work closely with team team(s) to manage the Regulatory operations activities :
• Development, implementation and maintenance of regulatory systems pertaining to regulatory document management (SOP's, archival and systems) within the department and organization.
• Effective implementation of corporate/APAC/Local Projects as per timelines and report the progress to management.
• Support for managing department training.
• Keeping a track of department tracker, dashboards and report to management.

Candidate Profile
• B.Pharm / M.Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs
• Must have at least 4-6 years’ experience in the pharma/medical device/life science industry with at least 2-3 years' medical device experience in regulatory affairs
• Conversant with various regulatory requirements for India, Sri Lanka, Bangladesh & Nepal with respect to medical device registration, import, clinical trials, etc.
• Knowledge in application of CDSCO, FDA, CE and other regulatory requirements especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release
• Excellent communication and interpersonal skills - Good verbal communicator and presenter
• Customer focused:  Understands and delivers customer service
• Ability to quickly establish credibility with all levels of Regulatory Agencies, Government, etc.
• Good verbal and written communication skills in English - with colleagues, management and external authorities
• Self-motivated and positive "Can do" attitude. Can work autonomously but is also a team player
• Outgoing and friendly:  Enthusiastic, energetic, diplomatic, willingness to learn
• Be able to plan, manage, organize and report in an efficient way
• Be independent, persuasive, innovative and able to summarize
• Good time management:  Well organized, able to set and reset priorities
• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

Additional Information
Experience : 2-6 years
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Gurgaon, Haryana
Industry Type : Pharma
Functional Area : Sales
End Date : 25th December, 2018

Require Deputy Manager/Assistant Manager at Teva Pharmaceutical

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.

Post : Deputy Manager/Assistant Manager - Quality Control

Job Description
Role and responsibility:
This position reports to the Head - Analytical Laboratory and is responsible for review of Technical Data Package, plan and perform Stability analysis / Method Verification / Method Transfer / Validation, review of all analytical data, review of departmental SOP’s and training. Responsible for handling of Quality forms in Track wise, Track wise Harmony and handling of documents in Glorya EDMS.

Main tasks:

• Planning / performing Stability analysis, Method Transfer and Method Validation: Planning for execution of Stability analysis, Method Transfer and Method Validation as per the relevant protocols, execution of pre-analysis based on the Technical Data Package / Verification and development of methods such as Assay, Related substances, Dissolution etc. for a drug as per the requirement. Review and maintenance of all log books of the department.
• Review of Technical Data Package:Review of Technical Data Package for stability drug products, to evaluate the feasibility of the method and to know the requirements, review of Method Transfer Protocol and Standard Testing Procedures in compliance with current guidelines, review of all stability/ method transfer/ method validation reports and analysis data.
• Review of Method Transfer / Method Validation protocols for drug products.
• Review of stability/ Method transfer and Method validation data. Method development and method verification for drug products.
• Review of departmental SOP’s, Calibration, Equipment validation protocols and Reports, review of departmental SOP’s, equipment validation protocols / data and calibration reports in compliance with current guidelines. Ensure the departmental activities are in compliance to cGMP
• Review and maintenance of all log books of the department.
• Initiation of Quality forms in Track wise, Track wise Harmony and handling of documents in Glorya EDMS, initiation of Quality forms in Track wise, Track wise Harmony and handling of documents in Glorya EDMS.

Candidate Profile
• Should have Masters in Analytical Chemistry/Chemistry/ M.Pharm
• Must have 10+ years of experience in an analytical lab with most recent experience being in formulation.
• Should be knowledgeable in HPLC GC (instrumentation),  Empower and LIMS(tools)
• Good knowledge in trouble shooting analysis
• Good interpersonal and communication skills
• Analysis of method transfer and stability analysis.

Additional Information
Experience : 5+ years
Qualification : M.Pharm, M.Sc
Location : Chennai
Industry Type : Pharma
Functional Area : QC
End Date : 25th December, 2018

Work as In vitro ADME at Syngene @ Apply Now

Post : In vitro ADME

Job Description
Job Purpose
A highly motivated individual with strong interest in in vitro ADME assays is required for SARC (Syngene Amgen Research center) collaboration. In this position, candidate will support compound screening efforts in standard in-vitro ADME assays.

Key responsibilities:
• Perform in vitro ADME assays such as solubility, metabolic stability, CYP450 inhibition, plasma stability, TDI, IC-50 shift etc.
• Handling of hepatocytes for metabolic stability assessment in CLint assays.
• Analytical problem solving skills
• Hands-on experience in other common in vitro ADME assays is highly preferred

Candidate Profile:
• MSc (Chemistry/Biological Sciences)/M. Pharm from reputed University
•  3-6 years in industry
• Prior experience in standard in vitro ADME assays.
• Well versed with MS Office applications 
• Good communication skills

Additional Information
Qualification : M.Pharm, M.Sc
Location :  India
Experience :  3-5 Years
Industry Type : Pharma
End Date : 30th December, 2018

Require Associate Manager at Merck Limited @ Click Here for more details

Post : Associate Manager - Marketing

Job Description

• Proactive development of marketing strategies and promotional mix to meet brand objectives and customer needs.
• Market development, expansion and monitoring for assigned product towards achievement of key financials.  This involves market planning, forecasting and analysis.
• Development of launch plans and co-ordination of implementation including co-ordination of pre-launch activities
• Monitor business performance and external environment via appropriate tools to deliver corrective action as required to meet business objectives.
• Effective management of promotional budgets for brand.
• Work in close partnership with marketing, medical and all important stakeholder external partners to launch and drive M&S programs.
• Key input into all marketing agency selection and liaison with them to deliver initiatives for brand
• Design, Development, Execution and Monitoring of Brand Campaigns
• Full accountability for brand and delivery of all programs related to it.
• Garnering Customer (Doctors) insights through Field Work, Personal Dr Interviews, Round Table Meeting, CMEs, Advisory Board Constitution, Feedback Mechanism
• Support sales team to drive sales – work in close partnership with sales team to ensure implementation of marketing programs and achieve team goals
• Management of external agencies to meet team goals
• Acts as brand champion to create enthusiasm and focus internally and with external customers and agencies.
• Cross-functional interaction: work with Medical, Regulatory, SFE, Operations and other functions to launch marketing and sales programs

Candidate Profile
• B. Pharm / B.Sc and MBA Marketing from reputed Institute.
• Min of 3-5 years experience in Brand Management. The person should have experience and/or exposure to ethical brand management
• Exposure to Diagnostic and Targeted therapy segment will be added advantage. Prior sales experience or experience in launching brands will be an added advantage though not a necessity
• Strategic thinking
• Analytical skills
• Hands on execution skills
• Market Research
• Worked with agencies - PR/ Advertising
• Knowledge about marketing process and planning tools
• Experience in designing and executing communication strategies
• Excellent Communication and Interpersonal skills
• Computer Proficiency
• Commercially astute, with strong organizational and prioritizing skills, and the ability to succeed in a highly results-driven environment
• Ability to work in a complex and constantly evolving environment
• Passionate and able to work and deliver against short deadlines
• Ability to listen and engage
• All round standards of professionalism and integrity
• Excellent training and presentation skills
• Willingness to travel – within India and abroad

Additional Information
Experience : 3-5 years
Qualification : B.Pharm, B.Sc, MBA
Location :  Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Marketing
End Date : 30th December, 2018

Require Quality Assurance Officer at Johnson & Johnson @ Apply now

Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices & Diagnostics, which are independently managed and report into their respective Global business segments.  J&J Medical India (JJMI) is the market leader in the Medical Company Devices & Diagnostics Industry in India. It is in the business of caring and providing solutions to doctors, patients and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Orthopaedics, Infection Prevention, Wound Management, Women’s health, minimally invasive surgery, Circulatory disease management.

Post : Officer- Quality Assurance

Job Description
Role Overview: To ensure compliance to the requirements of Good Manufacturing Practices (Schedule M of D&C Act) during manufacturing of the Cosmetics product in the plant. To ensure robust deployment of all Quality System elements across all GXP functions at the plant. To ensure compliance to the requirements of Good Laboratory Practices (Schedule L-I of D&C Act) in the Quality Control Laboratory, enabling timely & accurate disposition for incoming materials, intermediates, bulk & finished products manufactured at the plant.

Illustrative Responsibilities:
• Ensure effective implementation of Good Laboratory Practices, Good Manufacturing Practices & Good Documentation Practices in the plant.
• Carryout Sampling & Testing of Raw & Packaging Materials, Intermediates, Bulk & Finished Products, as per the validated analytical test methods enabling timely & accurate disposition decisions.
• Carryout in-process quality assurance checks during manufacturing of various products, to confirm adherence to validated processes.
• Review & approval of Manufacturing Batch Records, Test reports & other GXP documents, enabling finished product releases in SAP for dispatch to market.
• Conduct investigations related to Non-conformances, Deviations & Market Complaints and build robust CAPA to avoid recurrences.
• Conduct Risk Assessments on changes in Men, Materials, Machines, Methods and drive compliance.
• Ensure proper execution & documentation of the Qualification (DQ, IQ, OQ & PQ) for the Laboratory and Manufacturing Equipment.
• To participate in deployment of Enterprise Quality Policy Standards, Technical standards, WWSPs, QSPs, local SOPs applicable to the site. Conduct GXP trainings and drive effectiveness.
• Active participation in plant Gemba round and ensure timely closure of the observations.
• Stability Management for the site, which includes preparation of MPS protocol, Stability reports, Stability Planner & Management of Stability Chambers etc.

Candidate Profile
• Education: Master’s degree in Pharmacy or Chemistry from a reputed university.
• Sound knowledge of GMP, GLP and Regulatory Compliance.
• A minimum of 4+ and up to 6 years of experience in Quality Assurance/Control function of a Pharmaceutical/Healthcare/FMCG Company.
• Should be willing to work in shifts (A, B & C), 24x7 with staggered weekly off.
• Good communication & interpersonal skills, flair for quality, team player, quick learner.
• Candidates with Himachal Bonafide will be preferred.

Additional Information 
Experience : 4+ years
Qualification :  M.Sc./ M.Pharm
Location : Himachal Pradesh
Industry Type : Pharma
Functional Area : QA
End Date : 30th December, 2018

Apply for Regulatory Assistant at AstraZeneca @ Click Here for more details

AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.

Post : Regulatory Assistant

Job Description
Accountabilities/Responsibilities:
• Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements
• Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
• Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals.
• Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation
• Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser
• Provide coaching, mentoring and knowledge sharing within the RPM skill group
• Contribute to process improvement

Candidate Profile
• Relevant qualification and/or experience in science, administration or IT
• 2 - 5 Years’ Relevant experience from biopharmaceutical industry, or other relevant experience
• Proficient verbal and written English
• Project Management skills
• Experience in document management and tracking databases

Preferred Experience
• Some regulatory/medical/technical experience
• Knowledge of AZ business and processes
• Some knowledge of AZ submission, compilation, publishing and approval processes, standards, systems and tools
• Experience of working with people from locations outside of India, especially Europe and/or USA

Skills and Capabilities
• Good written and verbal communication skills
• Cultural awareness
• Proficiency with common document management tools
• Ability to work independently and as part of a team
• Continuous Improvement and knowledge sharing focused

Additional Information
Qualification : Bachelors or Masters Degree
Location : Bangalore
Industry Type : Pharma
Functional Area : Product Regulatory Affairs
End Date : 30th December, 2018

Require Associate Scientist at Johnson & Johnson @ Click Here for more details

Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives.

Post : Associate Scientist

Job Description
Position Summary/ Role Overview: The objective of this position is to deliver analytical services to various global consumer R&D sites. The position demands a data reviewer/technical writer role to manage the analytical activities with a compliance focus under the supervision of J&J analytical team leader.

Job Responsibility:
• Excellent technical writing skills: Drafting, articulation, correctness of language, word/excel/power point formatting and use of appropriate features
• Adequate knowledge related to chemistry, analytical techniques, stability study assessment and research technologies
• Technical skills related to data review, interpretation of analytical data and accurate documentation of laboratory investigations, NC and CAPA, change control, impact assessments, etc.
• In depth knowledge of GMP, quality systems, SOPs, latest regulatory trends, and global regulations as appropriate
• Technical skills related to interpretation of analytical data and accurate documentation of laboratory investigations and non-conformances
• Ability to independently plan, prioritize and execute assigned deliverables
• Ability to connect with cross functions and global partners and collate information.
• Excellent oral and written communication skills
• Ability to connect with cross functions and global partners and collate information.

Candidate Profile
Minimum Masters in Chemistry/Pharmaceutical sciences or similar technical discipline.

Additional Information
Qualification : M.Sc, M.Pharm
Location : Maharashtra-Greater Mumbai
Industry Type : Pharma
Functional Area : R&D
End Date : 25th December, 2018