Job Title:

QA - Process Validation Supervisor

Business Unit:

Global Quality & Compliance

Job Grade

G11B

Location :

Pithampur

Responsibilities

At Sun Pharma, we commit to helping you Create your own sunshine - by fostering an environment 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 team-oriented 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 of smoke study protocol, execution and review of smoke study video.
4. Review of intervention procedure and trending of intervention.
5. Preparation of aseptic process simulation protocol and reports.
6. Preparation and review of process validation and packaging validation protocol and reports
7. Preparation and review of cleaning validation protocol and reports.
8. Preparation and review of transport validation protocol and reports.
9. Review of equipment qualification documents for sterile facility. (eg.



Vial washing, tunnel, isolator, steam sterilizer, terminal sterilizer, lyophilizer, LAF, filling and sealing)
10. Review of utility qualification documents. (WFI, PSG, Compressed air, Nitrogen system etc.)
11. Review of HVAC qualification, clean area equipment (LAF, DPB) qualification and BMS/ EMS qualification documents
12. Initiation and review of QMS element in Software (Change control, deviation, CAPA etc.)
13. Responsible for performing investigation and identify root cause in coordination with CFT.
14. Perform quality transactions in SAP HANA system.
15. Coordinate with cross-functional teams (Production, QC, and Engineering) to align with project timelines.
16. 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

: 8+ 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.

📌 Senior Executive (Mumbai)
🏢 SUN PHARMA
📍 Mumbai