FDA Approved/QA Assistant Manager (Quality Assurance) Pharmaceutical/Dombivli MH

FDA Approval is required1. 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. 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 cases8. Responsible for review of MSDS and approval9. 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

4 - 10 Years

No. of Openings

6

Education

B.Pharma, B.Sc, M.Pharma, M.Sc

Role

QA Assistant Manager

Industry Type

Pharma / BioTech / Clinical Research

Gender

[ Male / Female ]

Job Country

India

Type of Job

Full Time

Work Location Type

Work from Office