1+ months

GT&E Associate

+ 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.

+ Finalize manufacturing Process and Parameters/ CPPs for Scale up, Pre Exhibit, Exhibit, Process validation batches and Commercial batches.

+ 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.

+ 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 Bill of Materials etc.

+ Ensure compliance to cGMP/ cGLP, organizations procedures and practices.

+ Ensure effective safety systems are implemented in the premises.

+ Serving as a key scientific and technical representative for process-related issues at the facility.

+ Partnering with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.

+ Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.

+ Identifying and implementing potential process improvements in conjunction with manufacturing operations.

+ Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.

+ Prepare/Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.

+ Establish small-scale production processes and using scaled-down lab processes to enable process and analytical troubleshooting.

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



Posted: 2020-05-01 Expires: 2020-08-01

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GT&E Associate


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