Sr. Consultant - Executive Search at STRIKE-IT-RITE MANAGEMENT CONSULTANTS PRIVATE LIMITED
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General Manager - Quality Assurance (18-24 yrs)
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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