Require Purchase - FDC at Syngene International @ Click Here for more details

Post : Purchase - FDC

Job Purpose 
Responsible for achievement of business objectives by ensuring timely supply of requisite input materials i.e. raw materials, consumables, samples, solvents, reagents, packing materials, spares, stationeries etc; Periodic follow ups with all the stakeholders, service both internal and external customers, manage the deliveries to meet the organization standards as well to meet the requirements of regulatory authorities.

Key Responsibilities

• To track PR from the end users
• Sourcing right vendors globally for customized products
• Completing VQ and necessary documentation as per GMP protocol
• Coordination with cross function team for licensing requirements.
• Good negotiation with vendor for Pricing, Quality, incoterm etc., and release the PO timely
• Intensive follow-up with vendors for prompt deliveries
• Achieve the delivery schedules as committed
• Complying with Safety and Regulatory requirements
• Trouble shooting and influencing with the team
• Follow-up with finance for payments to the vendors
• Bringing good industry practices and Striving for continuous improvements

Technical /Functional Skill:
• Working experience in CRO, CMO, Pharma field inventory management
• Knowledge of cGMP and Pharma regulations.
• Knowledge of SAP, ERP MM module.
• Computer literate (MS Office)
• Sound knowledge on API, Impurities, Working Standard, Excipients, and Packing materials
• Knowledge on GMP, USFDA
• Good knowledge on Import regulations for licensed and restricted products.
• Exposure in Pharmacopeial Standards
• Understanding about SEZ, EOU rules,
• Negotiation skill and vendor development

Candidate Profile
B.Sc /M.Sc with chemistry as one of the subject in degree studies or B.Pharm, 0-3 years in API, excipient procurements

Behavioral/Managerial Skills:
• Good communication
• Time management
• Positive attitude
• Customer Centric
• Result oriented

Additional Information:
Location: Bengaluru
Education: B.Sc, M.Sc or B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Purchase
End Date: 24th May, 2019

Apply for Project Manager at Syngene International @ Apply Now

Post : Project Manager II

Job Description
This role will support projects in Biologics center in Syngene.  The individual should have excellent communication skill to manage the internal stakeholders as well as manage client understanding. Ability to influence people without any authority.  This person would have proactive leadership skills and ability to manage the changing client and CRO environment. This individual will be responsible for ensuring the projects are delivered on time, budget and quality.  This individual should be well-versed Technology transfer, Scale-Up, Manufacturing & outsourcing scenarios of Large molecule manufacturing.

Responsibility
• Manage all the five levers of Project management: initiation, planning, execution, monitoring & control and closing.
• Work with the BD team to complete proposal efforts including project scoping.
• Create and execute project include change scope.
• Conduct risk analysis and prepare mitigation strategies where necessary.
• Coordinate multidisciplinary activities to ensure that the project deliverables are met.
• Identify resources needed and work with section heads to assign individual responsibilities.
• Effectively apply PMI methodology and enforce project standards.
• Conduct internal and external project review meetings
• Stakeholder and sponsor management on the projects
• Customer relationship management involving, effective communications with the client seek new opportunities and manage client expectations.
• Motivate team to work together in the most efficient manner.
• Keep track of lessons learned and share those lessons with team members.
• Mitigate team conflict and communication problems.
• Work closely with technical teams to improve the operational efficiency, facility mapping and capability enhancement.
• Track and report team hours, budget and resource utilization
• Analyze project profitability, revenue, and margins
• Timely updated on management information systems
• Identify process improvements for projects and functions.

Candidate Profile
• Masters in life sciences with background in large molecules (Biological) process development and manufacturing like Biosimilars, antibodies, Biotherapeutics etc or Master’s in Business administration with project management experience in Biopharma industry
• Preferably, PMP certified project manager with 6-8 years of project management experience  in Contract research organization or pharmaceutical industry (over all industrial experience 11-14 years)
• Added advantage with six sigma, Prince 2, Agile certifications.
• Experience in leading projects and managing client relationships
• Worked in GLP, cGMP and 21 CFR Part 11. Good understanding of product development lifecycle.
• Well versed with Microsoft office tools like excel, Microsoft project, word & PowerPoint etc
• Effective communication skills in English

Additional Information
Experience : 5+ years
Qualification : M.Sc, MBA
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Project
End Date : 25th May, 2019

Walk in Interview at Syngene @ 13.04.2019

Assistant Manager at Syngene International @ Click Here for mroe details

Post : Assistant Manager

Job Description
• Qualification and re-qualification expertize related to Equipment, Instrument, Facility and Area
• Experience in Computer system validation in line with 21 CFR part 11 compliance, GAMP 5, ICH Q9 followed by EU Annex 11 related to all computerized systems.
• Expertize in Gap analysis related to Equipment/Facility/Systems
• Expertize in validation of the Critical utilities like Purified water system, WFI, PSG, Nitrogen and etc
• Experience in HVAC installations and validations followed by periodic re-validations
• Thorough knowledge in statistical analysis and different tools of risk management application
• Exposure in Temperature mapping activity of specific areas
• Review and evaluation of Change controls, Deviations and CAPA related to equipment, systems and facilities followed by having good presentation skills in training the CFTs
• Having very good knowledge in preparing SOPs, EOPs and exposure in review and approval of equipment master list, PM and Calibration planners.
• Expertize in carrying out investigations related to equipment and facilities
• Calibration document reviews and approvals
• Handling of SAP related activities which includes improvement and troubleshooting plans
• Exposure to Internal Audits, Customer Audits and Regulatory Audits which includes the preparation for audit, providing timely effective response for the same.
• Timeline conscious in delivering the requirements
• Experience in API/QC/Development lab facility is preferred.
• Expertise in best quality management system, preparing, reviewing and approving all the qualification documents, QMS documents, validation documents and any cGMP documents related to Chemical development and other areas
• To be well versed with CAPA, internal audit, vendor audit and the other cGMP activities.
• To be stationed at Mangalore and travel to Bangalore if needed.

Candidate Profile
• Education qualification might be with BE in computer Science or M.SC in CS or M.Pharm or equivalent having experience of
• Qualifications and requalification of Equipment/Facility/Systems, critical utilities like Purified water system, WFI, PSG, Nitrogen and etc followed by conducting the gap analysis for equipment/systems.  Experience in Computer system validation in line with 21 CFR part 11 compliance, GAMP 5 and EU Annex 11 guidelines.  Expertize in validation of HVAC installations and validations and exposure in Temperature mapping activity of specific areas
• Review and evaluation of Change controls/Deviations and CAPA related to equipment and facilities and expertize in carrying out investigations related to equipment and facilities if any
• Calibration document reviews, Expertize in Gap analysis related to Equipment/Facility/Systems and Knowledge in statistical analysis and risk management tools application and exposure to SAP is essential.
• To handle Service provider Audits and FAT, Exposure to Internal Audits, Customer Audits and Regulatory Audits and knowledge in Area Qualification and experience in API/Formulation/Biologics/QC/Viral testing facility is preferred.

Additional Information
Qualification : M.Pharm
Location : India
Industry Type : Pharma
End Date : 30th April, 2019

Walk in Interview at Syngene @ 30.03.2019 Noida

Require Senior Research Associate at Syngene International @ Apply now

Post : Senior Research Associate

Qualification : M.Sc Chemistry
1-7 years of experience into relevant industry

Work Location : Genome Vally, Hyderabad

Job Id : 4044

Walk in Interview
Date : 24th March, 2019
Venue : Hotel Minerva Grand
Sarojini Devi Road, Secunderabad
Telangana - 500003
Timings : 08.30 AM to 11.00 AM

For more details please write to :Subramaniyan.venkatesh@syngeneintl.com

Walk in Interview at Syngene Hyderabad @ 24 March 2019

Vacancy for M.Pharm, M.Sc as Bioanalytical Auditor at Syngene International

Post : Bioanalytical Auditor -GCP QA 1

Job Description
• Should be able to perform project specfic bioanalytical, pharmacokinetic (PK), statistical  processes and data audits as per the QA SOPs and  audit programmes to ensure compliance with inhouse bioanalytical, pharmacokinetic / statistical SOPs and applicable regulatory guidances as GCP QA bioanalytical auditor as per the scheduled timelines for Clinical Development Business unit.
• Should be able to perform audits and review of processess, raw data  and documents including SOPs of bioanalytical method development, method validation, study sample analysis & reports to ensure the compliance as per the applicable regulatory guidance and inhouse bioanalytical SOPs.
• Should be able to perform audits and review of processess, raw data  and documents  including SOPs of pharmacokinetic/statistical data management, analysis & reports to ensure the compliance as per the applicable regulatory guidance and inhouse pharmacokinetic/ statistical  SOPs.
• Should be able to perform QA review (whenever required) in the bioanalytical and pharmacokinetic/ statistical sections of the study protocols.
• Should be able to assist or conduct periodic internal quality system or facility audits in different processes, instrumentation and software applications and its documentation in bioanalytical and pharmacokinetic/ statistical departments.
• Should be able to assist or conduct whenever required audits of quality system or facility, as part of regulatory inspection/sponsor audit readiness program.
• Should be able to prepare and issue audit reports and follow-up the implementation of CAPA to ensure closeout of the audits observations. whenever required assist manager/HOD to collate quality systems data for trend analysis of QA metrics.
• Should be able to prepare QA statements for bioanalytical validation reports and final study (PK & Statistics part)  reports as per the scheduled time lines.
• Should be able to assist or conduct onsite or desktop audit of vendors as per the vendor   assessment/reassessment schedule
• Should be able to perform QA review SOPs for bioanalytical process, instrumentation and pharmacokinetic/ statistical process to ensure the compliance with internal SOPs, Principles of GLP, GCLP, GCP, GDP and other applicable regulatory requirements.
• Should be able to efficiently and professionally provide the required deliverables as bioanalytical QA auditor for GCP quality function.
• Should be able to author SOPs for GCP quality assurance function or other relevant function’s SOPs and conduct training of relevant SOPs to staff of Clinical development Business unit.
• Should be able to periodically update and maintain own training records/binder and whenever required develop training plan and material and train the trainee auditors, trainee QC.
• Should be able to be responsible for delivering discussions /presentations on topics relevant to GxPs to the research staff.
• Should be able to collaborate with Bioanalytical /PK/Statistical  functions in lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.
• Should be able to update and consult manager/HOD when delivering the current job responsibility and escalate immediately any quality and noncompliance observations to Head of GCP Quality and Compliance.
• Should be able to perform or assist any other relevant job with relevant training as and when required by Head- GCP Quality and Compliance or Management.
• Should be able to periodically update the required technical, scientific, regulatory affairs knowledge with respect to the required national & international drug regulatory guidance and quality standards.

Candidate Profile
• Master Degree in Biochemistry/Biotechnogy/ Chemistry or M Pharm  QA /pharmaceutics/Pharmacutical analysis with at least 5-10 years related experience  as Bioanalytical Auditor  in GCP Quality Assurance and Clinical Quality Management Systems environment.
• Minimum experience required: 3-5 years in performing independently Bioanalytical / Pharmacokinetic/statistical audits and review in GCP environment.
• Through knowledge in Bioanallytical and PK/Statistical regulatory guidelines (ICH, USFDA, EMA, MHRA,) governing clinical development.
• Highly motivated, agile and organized individual who can function in a fast-paced, multi-tasking environment. Able to work independently and as part of a multi-disciplinary team
• Strategic thinking and goal oriented with demonstrated good judgment and decision-making experience in a matrix environment
• Excellent attention to detail, time management and investigative skills, able to manage multiple priorities with urgency and thoughtful planning
• Must have strong written and oral communication skills in English language.
• Experience working with MS Office (Excel, Word, PowerPoint)
• Ability to work with cross functional groups /teams and handle difficult people/situations under pressure.
• Ability to communicate clear and accurate audit observations based on regulatory requirements and best practice, which gains acceptance from auditees.
• Ability to work with the senior management level in QA and with other partnering departments of business units.
• Ability to deal with competing timelines.
• Ability to work independently and as part of a team.
• Ability to prioritize work and handle multiple assignments.

Additional Information
Experience : 3-5 years
Qualification : M.Pharm, M.Sc
Location : India
Industry Type : Pharma
End Date : 05th March, 2019

Apply for Manager at Syngene International @ Click Here for more details

Post : Manager
Job Description
• Has hands-on working experience on different solid oral manufacturing equipment (not limited) like RMG, roller compactor, powder blenders, tablet compression machines, Wurster processors, tablet coating machines, capsule filling machines, spray dryer and hot melt extruders.
• Additional work experience on parenteral and topical products is also beneficial
• Has developed products for ANDA/EU filing.
• Has basic understanding on the USFDA and EMEA guidelines for filing for drug products.
• Responsible for execution of development trial batches and GMP batches under the supervision of senior scientists in the team.
• Executes technical activities involving active pharmaceutical ingredients that may be potent or hazardous while following appropriate safety procedures.
• Works independently, supervised on a "weekly" basis, recognizes key issues likely to affect successful and/or timely completion. 
• For those issues that cannot be resolved by the project team, brings them to the attention of the line manager.
• Completes development reports and regulatory support documentation as required.
• Maintains an awareness of current scientific practice and current good manufacturing processes
• When requested, provides other support as required.
• Complies with Health, Safety and Environmental responsibilities for the position.
• Maintains current training records for required procedures.
• Complies with departmental and company policies.

Candidate Profile
M. Pharm (specialization in Pharmaceutics) from reputed Indian university with good academic track record.Atleast 0-3 years post M. Pharm and worked on development products meant for US/EU filing.

Additional Information
Experience : 0-3 years
Qualification : M.Pharm
Location : India
Industry Type : Pharma
End Date : 05th March, 2019

Research Investigator at Syngene International @ Apply Now

Post : Research Investigator-Imaging

JOB PURPOSE: 
The incumbent will join our Clinical IHC and Pathology team to provide support within the Immuno-oncology space, through the strategic application of cutting-edge pathology image analysis and bioinformatics approaches.  The successful candidate must have experience in utilizing pathology image analysis software in the quantification of IHC staining expression, including tumor/stroma classification and cellular feature extraction. The candidate should be able to perform statistical analyses and data visualization using data analysis packages such as R, Python, and/or MATLAB.

Principal Accountabilities/Responsibilities:
• Hands-on implementation/support of pathology whole slide image analysis tools and technology.
• Working alongside pathologist and scientists in the clinical IHC-pathology group to manage, prepare and analyze pathology whole slide images to support Immuno-Oncology and other disease areas.
• Perform bioinformatics analyses and data visualization, including analytics associating image analysis features with response and survival data using cox regression models, hypothesis testing, ROC analysis, and other statistical tools
• Active participation in the testing of pathology image management and analysis systems, tools and technology
• Prepare and present findings from image analysis projects to other groups within BBRC and BMS.
• Collaborate with other image scientists to propose, review and finalize future image analysis algorithm development and project work

Qualification and Experience
PhD in Biomedical Engineering, Bioinformatics, Computer Science or related discipline with 1-2 years of experience; or M.S. with 5-6 or more years of related experience in a pathology lab or pharmaceutical or biotech company.

SKILLS:
• Experience in any digital pathology analysis software packages is preferred
• Excellent programming skills in one or more analytics packages such as R, Python and/or MATLAB.
• Knowledge of various digital imaging scanner and/or experience imaging chromogen and fluorescent stains is desired.
• Prior experience in developing image analysis algorithms in feature extraction of tumor, stroma, and various cell types through stains and morphometric features is preferred.
• Has developed and deployed image analysis workflows for capture, organization and storage in a GLP-like environment.
• Strong problem-solving and collaboration skills, and rigorous and creative thinking
• Excellent written and oral communication skills, including an ability to collaborate effectively with lab scientists and pathologists
• Ability to work both independently and collaboratively, and to handle several concurrent, fast-paced projects.
• The ability to work across organizations to define and solve problems that will benefit the whole organizations.
• Capable of establishing strong working relationships across the organization.
• Background in Oncology/Immuno-Oncology is a plus
• Familiarity with tumor pathology, cancer biology and image analysis is preferred.

Additional Information
Experience : 1-2 years
Qualification : Ph.D, M.Sc
Location : India
Industry Type : Pharma
Functional Area : R&D
End Date : 27th February, 2019

RequireAssociate Scientist at Syngene International @ Apply Now

Post : Associate Scientist

Job Description:
- Perform computational experiments and data analyses that accelerate the discovery of high-quality drug candidates
- Work with other computational chemists and informaticians to discover new computational methodology and create workflows
- Understand data workflows in drug discovery to improve data delivery to end user scientists considering analytics and collaboration requirements.

Skills & Abilities:
- Understands the process of pharmaceutical discovery and the data and technologies employed
- Experience in applying molecular modeling methods to structure, ligand and fragment-based drug discovery projects
- Experience in ADME modeling and drug ADME profile optimization
- Proficiency in programming/scripting, working knowledge of databases
- Passion for problem solving and teamwork

Candidate Profile
MS in medicinal chemistry, pharmacology, cheminformatics, bioinformatics or related scientific discipline.

Additional Information
Qualification : M.Sc, M.Pharm
Location : India
Industry Type : Pharma
End Date : 20th February, 2019

Require Clinical QA Manager at Syngene International @ Apply Now

Post : GCP - Clinical QA Manager

Job Description:

• Schedule, personally conduct and/or manage  resources, for Good Clinical Practice (GCP), and CFR/Annex Part 11 audits which will support Clinical Operations activities including but not limited to :
• Develop risk based audit planning focusing on medical care of subjects/patients and adherence to protocols and GCPs for of clinical (BE /BA) operations and clinical site audits.
• Provide oversight for and participate in audits of clinical (BE /BA) operations, clinical sites and review clinical, pharmacokinetic/ statistical data and documents that will be submitted to regulatory authorities.
• Provide oversight of Clinical QA auditors to develop specific audit plans, review and assess internal audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and Best Practices.
• Collaborate with the appropriate Clinical Operations team in follow-up to clinical audits to ensure resolution of audit findings in accordance with industry best practices.
• Collaborate with Clinical Operations in lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.
• Consult with Clinical Operations regarding perceived GCP related vendor performance issues and when indicated work with them to develop a corrective action plan.
• When indicated perform remote vendor audits and provide follow-up as indicated.
• Provide follow-up corrective action with proposed and contracted vendor services.
• Lead/assist with investigations of misconduct, serious GCP breach and other noncompliance issues.
• Identify and appropriate escalate critical quality issues to GCP QA HOD.
• Perform / Oversee and root cause analysis (RCA) and corrective action preventative action (CAPA) process.
• Perform /Oversee internal process audits, due diligence, system audits, GCP document audits including trial master file (TMF), and 21CFR part 11 audits.
• Periodically maintain and report GCP QA team activity metrics, study quality metrics and trends for assigned program(s) to GCP QA HOD
• Assist GCP QA HOD/management in the readiness and hosting of regulatory agency inspections

Candidate Profile
• Master Degree in basic medical sciences / pharmacy/pharmacology with at least 12 years related experience in GCP Quality Assurance and Clinical Quality Management Systems.
• Minimum experience required: 10 years in performing and managing Clinical Quality • Assurance audits in GCP environment and with at least 6 years in team managing capacity.
• Through knowledge in regulatory guidelines (ICH, USFDA, EMA, MHRA,) governing clinical development.
• Highly motivated, agile and organized individual who can function in a fast-paced, multi-tasking environment. Able to work independently and as part of a multi-disciplinary team
• Strategic thinking and goal oriented with demonstrated good judgment and decision-making experience in a matrix environment
• Excellent attention to detail, time management and investigative skills, able to manage multiple priorities with urgency and thoughtful planning
• Must have strong written and oral communication skills in English language.
Experience working with MS Office (Excel, Word, PowerPoint)

Personal Attributes Needed.
• Ability to work with cross functional groups /teams and handle difficult people/situations under pressure.
• Ability to communicate clear and accurate audit observations based on regulatory requirements and best practice, which gains acceptance from auditees.
• Ability to work with the senior management level in QA and with other partnering departments of business units.
• Ability to deal with competing timelines.
• Ability to work independently and as part of a team.
• Ability to prioritize work and handle multiple assignments.

Additional Information
Qualification : M.Sc, M.Pharm
Location : India
Industry Type : Pharma
End Date : 10th January, 2019

Apply for Assistant Manager at Syngene International @ Click Here for more details

Post : Assistant Manager
Job Description:
• Qualification and re-qualification expertize related to Equipment, Instrument, Facility and Area
• Experience in Computer system validation in line with 21 CFR part 11 compliance, GAMP 5, ICH Q9 followed by EU Annex 11 related to all computerized systems.
• Expertize in Gap analysis related to Equipment/Facility/Systems
• Expertize in validation of the Critical utilities like Purified water system, WFI, PSG, Nitrogen and etc
• Experience in HVAC installations and validations followed by periodic re-validations
• Thorough knowledge in statistical analysis and different tools of risk management application
• Exposure in Temperature mapping activity of specific areas
• Review and evaluation of Change controls, Deviations and CAPA related to equipment, systems and facilities followed by having good presentation skills in training the CFTs
• Having very good knowledge in preparing SOPs, EOPs and exposure in review and approval of equipment master list, PM and Calibration planners.
• Expertize in carrying out investigations related to equipment and facilities
• Calibration document reviews and approvals
• Handling of SAP related activities which includes improvement and troubleshooting plans
• Exposure to Internal Audits, Customer Audits and Regulatory Audits which includes the preparation for audit, providing timely effective response for the same.
• Timeline conscious in delivering the requirements
• Experience in API/QC/Development lab facility is preferred.
• Expertise in best quality management system, preparing, reviewing and approving all the qualification documents, QMS documents, validation documents and any cGMP documents related to Chemical development and other areas
• To be well versed with CAPA, internal audit, vendor audit and the other cGMP activities.
• To be stationed at Mangalore and travel to Bangalore if needed.

Candidate Profile
• Education qualification might be with BE in computer Science or MSC in CS or M Pharm or equivalent having experience of
• Qualifications and requalification of Equipment/Facility/Systems, critical utilities like Purified water system, WFI, PSG, Nitrogen and etc followed by conducting the gap analysis for equipment/systems.  Experience in Computer system validation in line with 21 CFR part 11 compliance, GAMP 5 and EU Annex 11 guidelines.  Expertize in validation of HVAC installations and validations and exposure in Temperature mapping activity of specific areas
• Review and evaluation of Change controls/Deviations and CAPA related to equipment and facilities and expertize in carrying out investigations related to equipment and facilities if any
• Calibration document reviews, Expertize in Gap analysis related to Equipment/Facility/Systems and Knowledge in statistical analysis and risk management tools application and exposure to SAP is essential.
• To handle Service provider Audits and FAT, Exposure to Internal Audits, Customer Audits and Regulatory Audits and knowledge in Area Qualification and experience in API/Formulation/Biologics/QC/Viral testing facility is preferred.

Additional Information
Qualification : M.Sc, M.Pharm
Location : India
Industry Type : Pharma
End Date : 10th January, 2019