06 Sep
|
Pfizer
|
Ahmedabad
At Pfizer, our purpose is to deliver breakthroughs that change patients’ lives. Your work will leverage cutting-edge design and process development capabilities to accelerate and deliver best-in-class medicines to patients globally. Whether you are involved in discovery sciences, ensuring drug safety and efficacy, or supporting clinical trials, your contributions will be vital in helping Pfizer achieve recent milestones and make a global impact on patient health.
What You Will Achieve
In this role, you will:
- Finalize manufacturing Process and Parameters/ CPPs for Scale up, Pre Exhibit, Exhibit, Process validation batches and Commercial batches.
- Prepare and review technical data, Identifying and evaluating CPPs, Stability data, Annual Product Quality Reports, Technical documents.
- Coordinate with internal departments like Purchase, Analytical R&D;, Production, Quality Control, Regulatory Affairs, Quality Assurance, Project Management, Engineering etc., for seamless Technology Transfer.
- Plan for Technology Transfer process including various activities like procurement of API,
excipients, equipment for the developmental, Optimization, Scale up, Pre Exhibit and Exhibit batches manufacturing.
- Support to Regulatory Affairs for NDA/ ANDA filing activity and respond to Regulatory queries.
- Prepare and review necessary guidelines/ SOPs for Developmental/ Technology Transfer activities.
- Perform/execute process transfer strategies from site to site and PSci to site.
- Prepare study protocols/reports for scientific studies
- Stratification of data from engineering/EB/PVs for CQA trend analysis.
- 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, Batch Packaging Records and
📌 Scientist - Msat (Ahmedabad)
🏢 Pfizer
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