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 :

• 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 site's 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.

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

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