The Role
Senior QA responsible for reviewing and submitting exhibit batch manufacturing and packing records, process validation and hold-time protocols/reports, executed media fill records, equipment qualification documents, and QMS documents (change control, deviations, CAPAs) for regulatory submissions.
Summary Generated by Built In
- Responsible review of exhibit batch manufacturing records and exhibit batch packing records before execution of the batch.
- Responsible for review of process validation protocol and reports, hold time protocol and reports.
- Responsible for review of executed media fill records for regulatory submissions.
- Responsible for review and submission of executed exhibit batch manufacturing records and batch packing records.
- Responsible for review and submission of process validation reports and hold time reports.
- Responsible for review and submission of intended batch manufacturing records.
- Responsible for review and submission of product related equipment’s qualification documents.
- Responsible for review of QMS documents like Change control, deviation and CAPA.
M.Pharmacy or Any Postgraduate.
Skills Required
- M.Pharmacy or any postgraduate degree
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The Company
What We Do
DifGen Pharmaceuticals is a US-based global pharmaceutical company specializing in the development and manufacturing of complex, high-barrier-to-entry generic and specialty pharmaceutical products. The company focuses on creating dependable solutions in product development and commercialization to increase accessibility to high-quality medications, thereby leading to the creation of next-generation healthy communities.
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