Title:  Senior Executive

Job Title:

QA – Process Validation Supervisor

Business Unit:

Global Quality & Compliance

Job Grade

G11B

Location :

Pithampur

Responsibilities

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

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).