Manager - MSAT - Visakhapatnam/Vizag - Pfizer
- Pfizer
- 7 - 17 years
- Visakhapatnam
- 1 month ago
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Job Description
Use Your Power for Purpose
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring that customers and patients receive the medicines they need when they need them. By collaborating with our innovative engineering team, you will help accelerate the delivery of medicines to the world by envisioning new possibilities and taking decisive action. Your role is vital in making sure that the production processes are efficient and reliable, ultimately contributing to the well-being of patients globally. Join us in our mission to bring essential medicines to those in need, faster and more effectively than ever before.
What You Will Achieve
In this role, you will:
- Prepare and review Technical data, Gap Assessment, Risk Assessment Reports, Identifying and evaluating CPPs, Stability data, Annual Product Quality Reports, Technical documents from originating site.
- Design and execute Remediation activities like feasibility batches, Stability studies (R&D), Scaleup and Exhibit batches as per timelines for Existing molecules/ Products.
- Perform developmental activities for new molecules/ Products, NDAs, ANDAs, Literature survey, RLD characterization, Pre-formulation Studies, Prototype Formulations and Filter validation studies, Scaleup and Exhibit batches.
- Coordinate with internal departments like Purchase, Analytical R&D, Production, Quality Control, Regulatory Affairs, Quality Assurance, Project Management, Warehouse. SAP MES, Validation & Engineering etc. , for seamless Technology Transfer.
- Coordinate with external customers like Filter validation service providers & Vendors etc.
- Finalization of manufacturing Process and Parameters/ CPPs for Scale up and Exhibit batches manufacturing.
- Plan for Technology Transfer process including various activities like procurement of API, excipients, equipment s for the developmental, Optimization, Scale up and Exhibit batches.
- Support to Regulatory Affairs for NDA/ ANDA filing activity, respond to Regulatory queries and audit support.
- Prepare and review necessary guidelines/ SOPs for Developmental/ Technology Transfer activities.
- Technical support to Manufacturing Team for smooth launching of products.
- Trouble shooting, ongoing technical support to Manufacturing team for Process Validation, Continuous Process Verification and Process improvement.
- Prepare and Review of Scale up Protocols and Reports, Technology Transfer Protocols and Reports, Batch Manufacturing Records, Product Development Reports, Bill of Materials etc.
- Review of developmental work and guiding the Research Executives in Project work.
- Train newly joined Personnel.
- Ensure compliance to cGMP/ cGLP, organizations procedures and practices.
- Ensure effective safety systems are implemented in the premises
- Support in Investigations related to Process and Equipment to evolve CAPAs and monitor the effectiveness of CAPAs. Be able to apply DMAIC tool to drive investigation studies
- Performing day to day activities with Data Integrity Principles and Procedures.
Here Is What You Need (Minimum Requirements)
- PhD/ Masters in Pharmacy with any years of experience or associates degree with at least 10 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
- Demonstrated leadership, management, and technical capabilities
- Experience working with supply operations and enabling functions
- Proven project management, analytical, and problem-solving skills
- Strong understanding of packaging component suppliers
- Understanding of biological/vaccine requirements
- Strong written and verbal communication skills
Bonus Points If You Have (Preferred Requirements)
- Masters degree with relevant pharmaceutical experience.
- Practical experience in facilitating and conducting risk assessments
- Strong expertise in mammalian cell culture
- Knowledge of other heterologous expression systems
- Experience with regulatory submissions to support new products
- Ability to adapt to changing priorities and work effectively under pressure
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & Regulatory,
Role Category: Corporate Affairs
Role: Head - Regulatory Affairs
Employement Type: Full time
Contact Details:
Company: PfizerLocation(s): Visakhapatnam
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Keyskills: Procurement Manager Quality Assurance SAP Prototype Project management Analytical Formulation Packaging Manager Quality Control Technical support
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Pfizer
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We re looking for new talent to join our global community, to unearth new innovative therapies that make the world a he...
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