Require Deputy:Engineering Investigations Manager at Pfizer @ Click here for more details

Post : Deputy Manager - Engineering Investigations

Candidate Profile
• Should have Graduation / Post Graduation in Engineering or Pharmacy
• Should have 9 + years of experience in Engineering or Quality Assurance in Sterile Formulations Manufacturing facility
• Should be familiarized with pharma process and Utility equipment incident investigations including installation, commissioning, qualification and troubleshooting
• Should be familiarized with quality management systems (Incidents and deviations, Change control, CAPA and QRM)
• Should be familiarized with equipment PM and Calibration programs
• Should be familiarized with Projects management tools and techniques
• Should be familiarized with Quality Tracking System (QTS) for the management of investigations, CCFs and CAPAs.
• Should have exposure to USFDA and other regulatory inspections
• Should have trained in Method-1 and Method-2 (DMAIC approach) and Human performance Investigations
• Should have certification in Lean Six Sigma / Green or Black belt

Additional Information
Experience : 5+ years
Qualification : M.Pharm, B.Pharm,
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Engineering Investigations
End Date : 20th May, 2019

Recruitment drive in Chennai @ 15-16 April for Pfizer

Apply for Senior Associate in Quality System and Operations Support at Pfizer

Role Description

Our Global Quality Operations Mission is “to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.”  

Contract Operations Quality Assurance (COQA) drives excellence in Quality by maximizing our Partner collaboration to ensure Patients confidence in our Products.

COQA is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally. 

The person will be responsible for regulatory change management activities as a Site Compliance Network Member (SCNM) and management of routine product complaints for the Drug Products and Drug Substances (APIs) manufactured by Contract manufacturers.

Responsibilities:

Initiate, review and approve regulatory changes through PDM for changes initiated by or impacting COQA managed Contract manufacturers.

Provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.

Serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs in the Pfizer Country Offices (for Single market products) for the various regulatory activities involving COQA managed Contract manufacturers.

As the Regulatory Compliance and Product Complaint Expert, participate in Virtual Site Operating Teams (VSOT) (or similar) meetings for ES/COQA managed Contract manufacturers and if needed, participate in Site Quality visits at the Contract manufacturers.

Manage routine Customer Quality complaints for commercial Drug Products in PCOM and work in collaboration with the COQA Contractor Quality Lead  for ensuring that the investigation reports are appropriate and acceptable. Ensure timely closure of complaints and alerting the appropriate colleagues as per our procedure and Standard Work guidance.

Support and Perform Lot Disposition for Biotech products in collaboration with other functions.

Qualifications:

• Min. BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline
• Min. 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with Masters degree)
• Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms
• Good command of English language and multi-lingual is a benefit
• Strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural working environment
• Able to report remotely and deliver work independently
• Show strong negotiation skills and customer focus
• Is diplomatic in communication with internal and external customers
• Demonstrate ability to prioritize work, manage multiple projects, act and work independently and to report items as required to Team Leader
• Take initiative and be proactive
• Up to 10% travel required

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Require Head in Quality Operations at Pfizer @ Click Here for more details

Post : Head – Quality Operations

Key Responsibilities
• Quality oversight for Manufacturing and Packaging QA, Incoming Quality, Engineering QA, QC
• Laboratories, Investigations QA and Validation operations QA.
• Implementation of global quality policies, procedures and ensure their compliance
• Monitor quality indicators for operations and ensure controls are in place & maintained for cGM activities.
• Monitor Manufacturing and Packing activities to ensure compliance to the systems and procedures as per cGMP. e Responsible for trending of quality indicators in manufacturing operations.
• Provides technical, quality oversight and support to the SQOL in making quality decisions on corporate hold, High Risk Deviations from the manufacturing/packaging areas quality driven metrics.
• Ensures all investigations are appropriately investigated prior to batch release A system for batch release is developed and executed as a part of routine commercial operations. Mentor the team in current expectations of production and process controls to make quality decisions
• upstream of the process to mitigate downstream risk.
• Partnership with operations team for driving best practices.

ROLE RESPONSIBILITIES 
Complexity and Scope of Responsibility
Sets objectives for and manages multiple projects/ ongoing work activities of moderate complexity within Sub Business Unit/Sub Operating Unit

Resource Utilization
Manages and leads people, technological and financial resources at the Sub Business
May lead by influence rather than direct authority

Breadth and Depth of Knowledge
Provides technical / functional leadership to teams
Leverages technical/functional expertise across own and related disciplines.
Demonstrates comprehensive industry knowledge.
Exhibits business expertise and an understanding of the external marketplace and customer requirements

Knowledge Sharing
Actively shares knowledge with others across multiple Sub Business Unit/Sub Operating Unit through existing knowledge sharing processes/systems
Encourages others to share knowledge across the organization.

Innovation and Risk-Taking
Identifies existing process/product improvements
Develops innovative, advanced new concepts that improve processes / products across own and related disciplines
Takes appropriate risks to achieve desired results

Complexity of Decisions (e.g., Ambiguity, Complexity of Solutions)
Solves complex problems, where previous experience outside of own area may be relevant.

Impact of Decisions
Decisions impact multiple Sub Business Unit/Sub Operating Units mid-term objectives
Significant or long-term decisions are reviewed by senior management

Vision, Strategy, and Business Alignment
Establishes operational activities/projects that support mid-term goals and set direction for the Sub Business Unit/Sub Operating Unit.

People Management
Recognizes development needs and identifies/creates development opportunities (e.g., special assignments) for colleagues within own Sub Business Unit/Sub Operating Unit
Develops a talent base and anticipates development needs within the area of responsibility.
Manages performance of direct and indirect reports and support Sub Business Unit/Sub Operating Unit objectives through goal setting, ongoing assessment and coaching and performance evaluation.

Communication
Uses communication to help ensure alignment within and outside of Sub Business Unit/Sub Operating Unit
Creates and delivers presentations to direct reports and other internal stakeholders across Sub Business Unit/Sub Operating Unit.

Influencing Others
Manages teams that execute direction for the Sub Business Unit/Sub Operating Unit
Provides input to senior management decisions that may have an impact on business direction within the Sub Business Unit/Sub Operating Unit
Partners with Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit leadership to accomplish objectives.

Managing Change
Prepares for and manages change that impacts the Sub Business Unit/Sub Operating Unit.

Candidate Profile
Graduation or Post Graduation in Pharmacy or Science with 15+ years of experience in Quality Assurance or Quality Control, Preferably sterile dosage form facility.

Additional Information
Qualification : B.Pharm, M.Pharm
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Operations
End Date : 19th March, 2019

Require Senior Manager in Market Access at Pfizer @ Apply Now

Post : Senior Manager, Market Access

This role is primarily responsible for
• Designing and detailing the Market Access blueprint for Pfizer India’s 15-in-5 priorities
• Work with stakeholders in India commercial, enabling and global H&V functions in validating and implanting market access approach
• Develop innovative pricing, Govt. & payer partnership and patient models to enable Patient First approach for Pfizer’s innovative portfolio in India
• Program manage execution of market access enablers across relevant lines of business

Responsibilities
• Collaborate with Cross functional teams to gain in-depth understanding of Indian healthcare system & reimbursement scenario (e.g., OOP structure, funding barriers) and leverage insights to develop unique measures to address barriers and design brand/ TA specific access strategies
* Assessment of external access trends (e.g., new launch pricing, discounting trends, value based offerings, payer engagement models) to anticipate potential challenges and opportunities
* Analyze & identify opportunities to unlock access barriers at state and central level
* Identify best practices to issues/themes, develop disease pathway insights (prevention, diagnosis, therapy, follow-up)
* Knowledge and some experience of working in Oncology and Immunology portfolios and market trends / competitor pipeline in India
• Leverage historical success and current market trends to build pricing strategies for pipeline & existing portfolio
* Design financial models / scenarios to test future pricing options and provide input to larger commercial strategy for launch of new products
* Engage and influence senior leadership within the organization, regarding marketplace trends, business opportunities & threats, competitive pricing trends, and recommendations for addressing them
* Collaborate with Commercial, Corporate Affairs, Finance and Legal teams to leverage insights for strategic pricing models, price change decisions and expanding reach for innovative patented portfolio
• Develop collaborations to the benefit of the patient, with service providers, with regulators, payers and other leading players in a TA to expand accessibility
* Develop payer and provider archetypes to define target market for focused expansion efforts
* Design innovative engagement / contracting models (e.g., bundling) and explore scope for outcome-based payment models / HEOR driven models / studies to maximize access
* Evaluate tiered pricing and second brand opportunities for innovative portfolio to gain molecule market share
* Explore possibility of collaboration with financing organizations (e.g., key health insurance, NBFC) to create financial models to maximize access to innovative drugs and shape the market for future 
• Explore next generation Patient Assistance models to bring in differentiation from other players and evaluate offering “beyond the pill” and “funding services” to drive new patient acquisition and/or increase adherence

Candidate Profile

• MBA/ Masters Degree with 10-12 yrs of experience in a consulting firm, or Pharma Company in a market access role, or in a development consulting firm or in Industry Bodies
• Knowledge of Indian Healthcare system including health policy & pharmaceutical industry dynamics and strong know-how of India Pharma Market
• Understanding of business models of industries outside of pharma viz. banking, micro-financing, hospitals & insurance
• Exposure to Global payer markets, contracting strategies and ability to derive relevant insights for India
• Experience in strategy development and / or interaction with senior leadership / clients
• Ability to build strong local and global partnerships to influence colleagues outside of direct reporting structure
• Ability to work effectively in a cross functional team-based environment and to partner with internal and external stakeholders
• Strong communication skills to interact with senior leadership.
• Ability to work independently; self starter to drive value creation.
• Track record of hands on style to both manage and deliver work product.
• Demonstrated ability to work with senior external stakeholders, ensuring Pfizer and its position & reputation are appropriately  represented and protected.

Additional Information
Qualification : M.Pharm, M.Sc, MBA
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Market Access
End Date : 30th January, 2019

Require Senior Executive in Regulatory Affairs at Pfizer @Apply Now

Post : Senior Executive - Regulatory Affairs.

Job Description
• Responsible and accountable for Submissions Management and delivery of regional and/or national regulatory dossiers to Worldwide Health Authorities.
• Lead and manage logistical and technical aspects associated with submission management, ensuring development and delivery of regulatory dossiers (initial application, lifecycle updates, compliance and maintenance) to Worldwide Health Authorities in line with the regulatory strategy.
• Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate.  Partnering with product teams and/or third-party partners, the incumbent will be responsible for project management of activities, in support of regional and national regulatory submissions component build and delivery.
• Delivering project specific Pfizer electronic and paper regulatory submissions.  Including co-ordination and execution of solutions that meet unique requirements of each submission and national market, management of product delivery to regulatory agencies and ensuring subsequent archival.
• Ongoing liaison with Project Team and country representatives to ensure paper and electronic submission requirements, translation requirements and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional and national markets.
• Actively participate in the definition, investigation and implementation of national, regional and global process efficiencies for paper and electronic submission execution, including the evaluation of current processes.
• Completion of assignments and tasks within a specific task force/project associated with electronic and paper submissions.
• Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.
• Contribute to effective forecasting and management of project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.
• Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
• Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
• Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.
• Promotes the use of Document Management and Archival systems and standard document authoring and publishing processes, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.

Knowledge and Skills:
Technical Skills
• In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
• Proven ability to embrace new technologies and drive their implementation
• Proven aptitude in project management and process re-design

Standards, Processes and Policies
• Strong knowledge of the drug development process, regulatory affairs, and submissions management;  demonstrating an understanding of regional and national regulatory filing guidelines and dossier requirements
• Strong understanding of build and delivery of human health electronic and paper regulatory submissions and electronic review aids as defined by FDA, EMA, MHLW and ICH.

Any other Skills
• Excellent oral and written communication skills.
• Demonstrated business acumen; strong organizational management skills, the ability to manage multiple demands simultaneously; the ability to respond to tight timelines in a highly regulated environment
• Proven aptitude in project management and logistics
• Ability to work on multiple highly complex projects simultaneously; demonstrated attention to detail.
• Ability to operate seamlessly and influence across organizations.
• Ability to manage or deliver through others in a global operating model
• Ability to manage a significant and diverse portfolio of work with cross-site and line teams.

Candidate Profile
Post graduate in Pharmacy / Science, Business or Information Technology
Minimum 4-  6 years experience in the Pharmaceutical Industry

Additional Information
Experience : 4-6 years
Qualification : M.Sc, M.Pharm
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Tracking Code : 4726774
Functional Area : Regulatory Affairs
End Date : 15th January, 2019

Require Trainee Executive at Pfizer @ Last date 15 Dec 2018

Post : Trainee Executive

Job Description : 
Position Purpose
Functions as an Annual Report Strategist for Brands-NDA Annual Report (AR) team, working with CMC Global Regulatory Strategist - CMC (GRS-CMC) and Cross Functional Teams to prepare and submits the CMC contributions of US NDA/ANDA/BLA/PMA/IND Annual Reports as per defined timelines.

Responsibilities
• Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines.
• Reviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the CMC GRL.
• Authors and/or compiles CMC contributions based on changes made during the appropriate reporting period, i.e. Module 1 & 3 under the guidance from the CMC GRL as appropriate and within agreed timelines.
• Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled
• Reviews technical/supportive information for submission to support AR changes
• Manages and reviews stability contributions for accuracy and consistency with commitments
• Reviews and applies pertinent US regulatory guidelines to confirm Annual Reportable filing classifications.
• Develops technical justification of change for agency submission as needed
• Updates impacted dossier components as needed
• Coordinates M3.2.R Ancillary documents as needed
• Escalates delays in timelines and flags identified risks to the CMC GRL and/or appropriate leadership
• Coordinates internal document review and sign off.
• Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc., as appropriate.
• Ensures compliance to Pfizer internal procedures and training SOPs (Power 2 Learn).

Candidate Profile
• Postgraduate in Pharmacy / Science
• Excellent oral and written English communication skills. Good conceptual and reasoning skills. Attention to details.
• Knowledge on Regulatory requirements of post approval changes  for US Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of ARs.
• Knowledge in retrieving information from company’s and regulatory agency databases.
• Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.

Additional Information
Qualification : M.Pharm, M.Sc 
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global Regulatory Affairs
End Date : 15th December, 2018

Require Labeling Operations Manager at Pfizer

Post : Labeling Operations Manager

ROLE SUMMARY 
The Labeling Operations Manager (LOM) provides operational support for the initial creation and relevant updates to labeling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents.  The LOM will be knowledgeable of labeling guidance and policies related to technical/formatting (e.g. QRD template, PLR format) and will raise awareness of important factors to consider when revising the label.  The LOM provides project management to the Labeling Team throughout the labeling review and approval process through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets, ensuring that Labeling Teams are aware of the review and approval timelines and following up with Labeling Team members throughout the process as appropriate so that deliverables remain on target to meet internal and external deadlines.

ROLE RESPONSIBILITIES
Support the review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents.
• Consolidate labeling versions
• Consolidate comments from Labeling reviewers and Regulatory Authorities
• Prepare comparison tables for labeling team discussions
• Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR)
• Generate necessary renditions in GDMS (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate
• Facilitate workflow through corporate document repository, e.g., GDMS.
• Utilize PfLEET2 to track labeling projects
• Finalize documents post QC (including update of GDMS document properties such as entry of PfLEET2 number, update of document title, update CDS cover page etc.).
• Manage the document status in GDMS and notify internal stakeholders of the availability of labeling documents.
• Order SPL for USPIs, check and upload to GDMS upon receipt, notify internal stakeholders of its availability (e.g., Regulatory, Drug Listing).
• The LOM will be responsible for updating related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics.
• Set clear targets for review and approval timelines for labeling documents using effective project management. Follow up with Labeling Team members to ensure timely review and approval deadlines are met.
• Update and maintain the CDS log.
• Identify and assist teams to overcome barriers in achieving quality and compliance.
• Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems. 
• Support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
•  Contribute to the development of continuous improvement of business practices. Advocate for new labeling initiatives to immediate labeling stakeholders

Candidate Profile
Bachelor’s degree required; science or life sciences field of study preferred.
Experience and Attributes:
• 2+ years experience in pharmaceutical or medical device industry required; pharmaceutical labeling experience preferred.
• Knowledge of global/regional regulatory guidelines and requirements important.
• Excellent written and verbal communication skills essential.
• Complete fluency in English Language.
• Proven strength in logical, analytical and writing ability essential.
• Demonstrated project management skills and attention to detail required.
• Identifies and resolves problems in a proactive manner.
Technical Skill Requirements
• Ability to assess and manage project timelines
• Ability to multi-task, prioritize and manage multiple projects
• Ability to identify and resolve problems in a proactive manner.
• Demonstrates appropriate decision making including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders
• Interpersonal and communication skills
• Ability to liaise with stakeholders using effective means of communication. Clear and effective written and verbal communication skills.
Technical competencies
• Ability to apply labeling regulatory guidance on formatting requirements 
• High attention to detail
• Ability to consolidate comments from multiple sources (e.g., emails, meeting minutes)
Systems and Document compilation skills, including:
• Must have excellent computer skills and demonstrated proficiency with Microsoft Word and similar applications
• Prepare submission ready documents
• Hyperlinking, pagination, Table of Contents (TOC) creation, etc. 
• Project Management capability and organizational skills

Additional Information
Qualification : B.Sc
Experience : 2+ years
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 5th December, 2018