Assistant Manager- Quality Assurance

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 heres how this role will make an impact.

Job Responsibilities:

1. To ensure compliance to GLP in QC Department.
2. Responsible for review and approval of analytical data of finished products, Raw materials, Packaging materials, In-Process, Swab samples, Validation samples, Water Samples and Stability samples.
3. Responsible for Preparation, Review and Approval of stability protocols, stability reports & grids.
4. Review and Approval of Certificate of analysis for finished product dispatch batches, Raw Materials, Packaging Materials, In-Process, Swab samples, Validation samples and Stability samples.
5. Review of Certificate of Analysis for working standards.
6. Responsible for preparation, review and approval of specifications and test procedures of raw materials, packing materials, in process materials and finished products.
7. Review of QC Department Instruments qualification documents.
8. Coordinate with the Affiliate sites and R&D department for specifications and method transfers.
9. Review and evaluation of change controls data for all changes which affects analytical procedures, methods, and QC instruments.
10. Review and Approval of method validations/verifications and analytical method transfer protocols & reports excel validation protocols and reports.
11. Updation of regulatory guidelines and periodically amending the work practices.
12. Responsible for Preparation, and approval for Master data in LIMS.
13. Preparation and review of SOPs through Documentum / D2.
14. Responsible for verification of stability sample withdrawal record.
15. Responsible for Audit trail review of QC instruments.
16. Ensuring the compliance of Product/Materials with current Pharmacopeias.
17. Review and Approval of CSV related documents.
18. Review of the analytical soft copy and sign-off -2 in all instruments as per requirement.
19. Review of the analytical document of hard copy in LIMS and approval of reviewed analytical data in LIMS.

Qualification and Experience:

1. Qualification- B.Pharm/M.sc

2. Should have around 10 years of experience in Quality Assurance