Job Title:

QA - Validation

Business Unit:

Global Quality & Compliance

Job Grade

G12A

Location :

Pithampur

Responsibilities

At Sun Pharma, we commit to helping you Create your own sunshine - by fostering an setting where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine

As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys.

1. Preparation and review of SOPs in EDMS.
2. Preparation and review of validation master plan.
3. Preparation and review of qualification documents (URS, cGxP Assessment, risk assessment, DQ, IQ, OQ, PQ and RTM).
4. Preparation and review of equipment risk assessment document.
5. Ensure fulfilment of regulatory requirement and compliance in the equipment qualification.
6. Review of equipment qualification documents for sterile facility. (eg. Vial washing, tunnel, isolator, steam sterilizer, terminal sterilizer, lyophilizer, LAF, filling and sealing)
7. Review of utility qualification documents. (WFI, PSG, Compressed air, Nitrogen system etc.)
8. Review of HVAC qualification, clean area equipment (LAF, DPB) qualification and BMS/ EMS qualification documents.
9. Review of temperature mapping protocol and reports for storage rooms, incubators, cold chambers.
10.



Review of temperature mapping protocol and reports for storage rooms, incubators, cold chambers.
11. Initiation and review of QMS element in Software (Change control, deviation, CAPA etc.)
12. Responsible for performing investigation and identify root cause in coordination with the CFT.
13. Preparation of smoke study protocol, execution and review of smoke study video.
14. Review of intervention procedure and trending of intervention.
15. Preparation of aseptic process simulation protocol and reports.
16. Verification of compliance and ensure engineering compliance:
17. Review of area logbook and GMP documents.
18. Review of Preventive Maintenance schedules.
19. Review of calibration schedules and associated documents.
20. Review of breakdown maintenance schedule, trending and associated documents.
21. Perform quality transactions in SAP HANA system.
22. Coordinate with cross-functional teams (Production, QC, Engineering) to align with project timelines.
23. Ensure continuous compliance with cGMP, data integrity, and sterile manufacturing guidelines.

Travel Estimate

NA

Job Requirements

Education Qualification

B.Pharma/M.Pharma/M.Sc.

Experience

Tenure

: 6+ Years

Disclaimer:

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Executive (Mumbai)
🏢 SUN PHARMA
📍 Mumbai