Manager / Senior Manager - Quality Assurance
20 hours ago
Role: Manager / Senior Manager - Quality Assurance
Job Location: Aurangabad (Chattrapati Sambhajinagar)
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via:
- Access Providing high quality trusted medicines regardless of geography or circumstance;
- Leadership Advancing sustainable operations and innovative solutions to improve patient health; and
- Partnership Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how this role, will make an impact:
Role & responsibilities
- Responsible for overall Management of specification and standard test procedure which includes preparation, review and approval at site.
- Review and Approval of Specification and Standard Test Procedure of Raw material / Finished products.
- Review and Approve Method Transfer /validation and verification analytical reports and Protocols.
- To coordinate for analytical method transfer/validation and verification from other locations and ensure the readiness of specification and standard Test procedure.
- To approve or reject the Certificate of analysis for Quality Control Release.
- Review of the change controls.
- Implementation and tracking of Pharmacopeial changes in specification and standard test procedure.
- Implementation and tracking of CEP and DMF notification of API.
- Support for Analytical documents required for regulatory submission.
- To approve the stability study data in LIMS.
- To review and approve working standard and Impurity Standard Qualification Protocols & Reports.
Qualification & Experience
- Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry
- Experience- Candidate must have 12+ years experience in reputed pharma Organizations.
- Candidates must be willing to work in shifts
- Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.
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