Job openings for quality assurance manager in palghar thane

FDA Approved/QA (Quality Assurance Manager) Pharmaceutical/PALGHAR EAST MH 01

Thane, Palghar


QA/Quality Assurance Manager/
FDA Approval is required
1. Responsible for the Preparation and review of master documents of QA department and review of all master documents and formats of respective departments other than QA.
2. Responsible for review of technical documents such as Technology Transfer, MPCR, BPCR, Specification and Standard test procedure, stability data, etc.
3. Responsible for preparation of training schedule and provide training on QA-related topics, guidelines, regulatory and cGMP requirements to all concerned employees.
4. Responsible for preparation and review and updation of Drug master file and handling of regulatory queries.
5. To evaluate quality and stability of finished APIs.
6. Responsible for organizing and execution of internal audit program, review of observations, follow ups and closures.
7. To investigate Out of Specification cases
8. Responsible for review of MSDS and approval
9. Responsible for preparation of annual product quality review.
10. Responsible for providing effective CAPA procedures, tracking completion and implementation of the same.
11. Responsible for validation activities as per validation master plan.
12. Responsible to investigate customer complaints and provide responses to customers regarding complaints.

Experience 7 - 10 Years
Salary 6 Lac To 12 Lac P.A.
Industry Pharma / R&D / Biotech
Qualification B.Pharma, B.Sc
Key Skills QA Quality Assurance Manager FDA Approved Required





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