Deputy General Manager - Sterility Assurance

sun pharma industries

15 - 20 years

15 - 19 Lacs

baska

Posted:8 hours ago| Platform:

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Skills Required

training assurance microbiology compliance pharma process improvement subject matter expert environmental monitoring technical support auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

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
Guide the investigation of contamination related non-conformance and events and provide technical input for microbiological method transfers.
Serve as subject matter expert on sterility assurance during regulatory inspections, audits and cross functional initiatives.
Support inspection preparation and execution during health authority on-site inspection as an expert in Sterility Assurance
Assess differences in current sterility assurance programs across the sites and drive harmonization
Provide mentoring leadership to site SMEs to help build continue to build capability on Sterility assurance program, where deep technical expertise is lacking
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.
Maintain compliance with governing regulations and lead by example in promoting best contamination control practices through ongoing training and floor presence
Collaborate with operations and QC micro lab to design and deliver robust training programs on aseptic processing, aseptic behavior and principles for site staff.
acting as the sites subject matter expert during audits
Identify opportunities for process improvement in aseptic techniques.
The lead mentors and develops junior sterility assurance staff and site SMEs to build technical expertise within the organization
Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.

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