Manager / Senior Manager - Quality Assurance VIATRIS

11.0 - 15.0 years

15 - 25 Lacs

aurangabad

Work from Office

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.

Posted 1 week ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.