Mumbai, Thane, Dombivli, Dombivli
1. Responsible for 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. To evaluate Quality and stability of finished APIs.
5. Responsible for organizing and execution of internal audit program, review of observations, follow ups and closures.
6. To investigate & approve Deviations, Out of Specification
7. Responsible for preparation, review of MSDS and approval
8. Responsible for preparation, review & approval of annual product quality review.
9. Responsible for providing effective CAPA procedures, tracking completion and implementation of the same.
10. Responsible for validation activities as per validation master plan.
11. Responsible to investigate & approve customer complaints and provide responses to customers regarding complaints.
12. Ensure handling, effectiveness and continuous improvement of the QMS System.
13. Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions
Experience | 6 - 8 Years |
Salary | 4 Lac 50 Thousand To 5 Lac 50 Thousand P.A. |
Industry | IT Software - QA / Testing / Documentation |
Qualification | B.Sc, M.Sc |
Key Skills | QA Senior Executive Quality Assurance Pharmaceutical |
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