Job Description
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 :
- Owning of Aseptic process simulation program of the site including protocol / operators and intervention qualification program / Trending and Aseptic process simulation summary report.
- Own and continually develop the Site's Contamination Control Strategy.
- Ensure Contamination control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
- Lead Sterility Assurance committee for the site .
- Review and approval of Microbiological environmental monitoring program, identify trends and implement effective risk mitigation
- G...
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