AM/Dy. Manager - Quality Assurance - Zuventus Healthcare Ltd-Sikkim
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Job Description
Role & responsibilities
- Overall responsible for QA activities.
- Monitoring of cGMP and GLP compliance and compliance to applicable regulatory requirement and filing commitments.
- To review and Approval / Reject the Quality Management System documents such as change control, deviation, CAPA, laboratory and production failures investigation, OOS, market complaints, product recall etc.
- To review and approve risk assessments.
- To perform self-inspection.
- To review and approved /Reject QMS documents.
- To prepare, review and approve the apex documents such as Site Master File, Validation Master plan and Departmental manual.
- Release of finished product to market.
Preferred candidate profile
- Having around 15 years of experience in QA in OSD.
- Having audit exposure of PIC/S, EU GMP.
- Having exposure of handling team.
- Age between 35 - 40 yrs
Skills
PharmaceuticalQuality AuditQuality MonitoringQuality ComplianceQuality ManagementQMS ImplementationHealthcareQualityQuality AssuranceIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
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