Job Description

Job Profile : Manager

Designation : Sr. Manager- QA

Job Description :

1. Approval of Quality documents such as SOP/QAP/MVP/BMRs/MFCs/Dept. manuals & all types of validation protocols/ AWRs, Reports, equipment qualification (DQ/IQ/OQ/PQ) etc.
2. Approving, change control, deviations, APQR, Product recall out of specifications results of RM/PM & Finished product & Out of Trend & investigation.
3. Approval of Approved vendor list of Raw Material/ Packing Material.
4. Approval of certificate of analysis of finish product. Manufacture at Vital Healthcare Pvt. Ltd.
5. Handling of Internal audits & vendor audit, Market complaint, return Goods, Change Control system, Deviation system, Out of specification, Corrective & Preventive action (CAPA), Incident reporting & investigation, deficiency of compliance of vendor audit & internal audit.
6. Preparation of audit compliance report,



Approval of self-audit schedule & training schedule.
7. Approving all procedures and changes affecting the quality of intermediates or APIs.
8. Approving all specifications and master production instructions.
9. Work distribution in QA dept. & Assign job responsibility QA employee.

10. Approval of Validation process, cleaning validation, analytical methods, equipment qualification & computer system.

11. To coordinate validations & ensure operation in plant with validation compliance.

12. Preparion of EDQM, USFDA, WHO, GMP & audit CAPA.
13. Training to all employees of 21CFR Part 11, ICH Q7 GMP & WHO TRS.
14. You are responsible of both unit for all QA activities.

Interested candidate can email their resume at [email protected] | [email protected]

📌 QA Head (India)
🏢 Vital Laboratories
📍 India