Brief Job Description :
- To Lead the CQA team and Ensure the harmonization of Procedures and practices related to QA, QC, R&D, & Production.
- Assuring compliance with GLP, GCP and GMP requirements, implementation of quality systems, inspections and checks during the design and development of pharmaceutical products.
- Assuring compliance with International regulatory operations including compilation of dossiers for drug application and submissions.
- To ensure Employee training on GLP, GMP & GCP.
- Act as a CAPA coordinator and internal Auditor .
- To conduct regular audit of Raw and Packaging Materials & Third party.
- To help regulatory affairs team .
- Proactively assess risk, plan and execute audit deliverables. Work with sites to ensure their systems are properly prepared for external and internal compliance inspections.
Job Specification :
Qualification : M.Pharma / PhD
Experience : 18 to 22 years experience and should have excellent track record in Pharma QA & QC. He /She should be working as AGM in Corporate QA in formulations. Should have good presentation and communication skill.
Candidate should be able to lead the team and possess excellent leadership quality.
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