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10/12 Aruna
Sr. Consultant - Executive Search at STRIKE-IT-RITE MANAGEMENT CONSULTANTS PRIVATE LIMITED

Views:1292 Applications:112 Rec. Actions:Recruiter Actions:0

General Manager - Quality Assurance (18-24 yrs)

Gujarat Job Code: 16711

With have an opening with leading Pharma MNC based at Hyderabad is looking for GM-QA for pharmaceutical MNC based at Ankleshwar,

Experience : 18+ years

- Responsible for overall activities of QA department at API Site.

- Responsible for regulatory compliance at site.

- Review & approval of various quality documents such as SOPs, Specifications, MOAs, GTPs, Qualification & validation Protocols/reports, BPR, ECR and Other Quality documents.

- Handling of Out of Specifications (OOS) and Out of Trends (OOT)

- Performing the annual product quality review (APQR)

- Monitor the quality of DMF filed products and validation batches

- Support to RA for DME submissions and plan the QA activities as per regulatory requirement

- Ensure timely release of batches as per defined time line and as per customer requirement

- Coordination with other department for issues related to QA

- Coordination with R&D/PRD/Production/QC/TT for technology transfer activities

- Imparting cGMP Training, On job training, Need Base training & other training to QA/QC staff and other departments

- Internal audits (Planning, execution to closure)

Aruna

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