1+ months

Senior Executive

Scientist should make significant and technical contributions to projects handled by the department. To work on products to increase, improve, or upgrade competency. To provide operational and Technical support for the seamless execution of submission & commercial batches.

+ Prepare and review technical data, identifying and evaluating CPPs, stability data, annual product quality reports, technical documents.

+ Coordinate with internal departments like 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.

+ To plan for technology transfer process which includes procurement of API, excipients, optimization, scale up, pre exhibit and exhibit batches manufacturing.

+ Support to regulatory affairs for NDA/ ANDA filing activity and respond to Regulatory queries as required.

+ 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. for IKKT products.

+ Train newly joined personnel.

+ Ensure compliance to cGMP, organizations procedures and practices.

+ Follow effective safety systems that are implemented in the premises.

+ Serving as a key scientific and technical representative for process-related issues for commercial products.

+ 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.

+ Participating in start-up efforts of new equipment, software or processes in manufacturing.

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

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

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

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



Posted: 2020-05-06 Expires: 2020-07-05

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Senior Executive


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