The Role
Review and submit exhibit batch manufacturing and packing records, validation protocols and reports, media fill records, equipment qualification documents, and QMS items including change control, deviations, and CAPA for regulatory submissions.
Summary Generated by Built In
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
- Postgraduate degree (M. Pharmacy or any postgraduate)
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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.
