▷ [15h Left] Sr.Manager / DGM - Sterility Assurance

4 days ago

Halol, India SUN PHARMA Full time

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)

  • Sr.Manager / DGM - Sterility Assurance

    8 hours ago

    Halol, India SUN PHARMA Full time

    Job Role : Sr.Manager / DGM - Sterility Assurance Location : Halol - VadodaraJob 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...

  • Sr.Manager / DGM - Sterility Assurance

    2 weeks ago

    Halol, India SUN PHARMA Full time

    Job Role : Sr.Manager / DGM - Sterility AssuranceLocation : Halol - VadodaraJob 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...

  • Sr.Manager / DGM - Sterility Assurance

    2 weeks ago

    Halol, India SUN PHARMA Full time

    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...

  • Sr.Manager / DGM - Sterility Assurance

    2 weeks ago

    Halol, India SUN PHARMA Full time

    Job Role : Sr.Manager / DGM - Sterility AssuranceLocation : Halol - VadodaraJob 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...

  • Sr.Manager / DGM - Sterility Assurance

    2 weeks ago

    Halol, India SUN PHARMA Full time

    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...

  • Sr.Manager / DGM - Sterility Assurance

    2 weeks ago

    Halol, India SUN PHARMA Full time

    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 /...

  • Sr.Manager / DGM - Sterility Assurance

    2 weeks ago

    Halol, India SUN PHARMA Full time

    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...

  • Sr.Manager / DGM - Sterility Assurance

    2 weeks ago

    Halol, India SUN PHARMA Full time

    Job Role : Sr.Manager / DGM - Sterility AssuranceLocation : 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...

  • Sr.Manager / DGM - Sterility Assurance

    2 weeks ago

    Halol, India SUN PHARMA Full time

    Job Role : Sr.Manager / DGM - Sterility AssuranceLocation : 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...

  • Sr.Manager / DGM - Sterility Assurance

    2 weeks ago

    halol, India SUN PHARMA Full time

    Job Role : Sr.Manager / DGM - Sterility AssuranceLocation : 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...