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13/11 sathish
Talent Acquisition at BVR People Consulting

Views:187 Applications:20 Rec. Actions:Recruiter Actions:6

Senior Manager - IPQA - Life Sciences (15-20 yrs)

Bangalore Job Code: 21389

Company : Leading Pharma Company in Mumbai

Department : Manufacturing Quality

Qualification : M.Sc, M.Tech, Ph.D. (Life Science)

Years of Experience : 13+ Years

Designation : Manager OR Sr Manager

Roles & Responsibility : 

Lead manufacturing QA team

1. Release and Issuance of BMR to production as per process order.

2. Monitoring, recording of observations related to;

- Personnel practices and procedures for any potential risk associated with the product quality

- Sampling practices and procedures for cross-contamination

- Labelling practices for any mix-ups

- Aseptic practices wherever applicable

- Facility cleanliness and maintenance observations

- Product handling practices for any potential risk of contamination and or cross-contamination.

- Escalation to function head and coordinate with manufacturing for implementation of CAPA

3. Review and approve MFR, BMR, SOPs, experiment study protocol/report, qualification document.

4. Ensure review and closure of discrepancy, change control, risk assessment, OOS, OOT, and CAPA effectiveness.

5. Assessment of batch trends for any out of trend (OOT) as part of continuous process monitoring and escalate to function head.

6. Review process validation and cleaning validation protocol for DS manufacturing facility and report closure on time as per regulatory guidelines.

7. Ensure audit readiness, shop floor oversight and GMP compliance.

8. Support in audit preparation, observation closure and report preparation.

9. Support In APQR preparation

10. QA connect for new product initiation in DS manufacturing facility and cross-functional requirement.

11. As continuous improvement, train QA, manufacturing team for GMP and GDP practices.

Interested & Eligible candidates kindly apply here :

Contact Person : Sathish Talent Acquisition - (7676336386)

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