Sr.Manager / DGM - Sterility Assurance

Job Role : Sr.Manager / DGM - Sterility Assurance

Location : Halol - Vadodara

Job Summary : In this Job role we are looking for Sterility Assurance, QMS elements for Sterile manufacturing Units with experience in Regulatory Audit Queries.

Responsibilities :

1. Owning of Aseptic process simulation program of the site including protocol / operators and intervention qualification program / Trending and Aseptic process simulation summary report.

2. Own and continually develop the Site’s Contamination Control Strategy.

3. Ensure Contamination control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.

4. Lead Sterility Assurance committee for the site .

5. Review and approval of Microbiological environmental monitoring program, identify trends and implement effective risk mitigation

6. Guide the investigation of contamination – related non-conformance and events and provide technical input for microbiological method transfers.

7. Serve as subject matter expert on sterility assurance during regulatory inspections, audits and cross functional initiatives.

8. Support inspection preparation and execution during health authority on-site inspection as an expert in Sterility Assurance

9. Assess differences in current sterility assurance programs across the sites and drive harmonization

10. Provide mentoring leadership to site SMEs to help build continue to build capability on Sterility assurance program, where deep technical expertise is lacking

11. Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the network.

12. Maintain compliance with governing regulations and lead by example in promoting best contamination control practices through ongoing training and floor presence

13. Collaborate with operations and QC micro lab to design and deliver robust training programs on aseptic processing, aseptic behavior and principles for site staff.

14. acting as the site's subject matter expert during audits

15. Identify opportunities for process improvement in aseptic techniques.

16. The lead mentors and develops junior sterility assurance staff and site SMEs to build technical expertise within the organization

17. Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.

Education : M.SC / B.Pharm / M.Pharma

Experience : 15+ Years (with Sterile / Regulatory Plants)