Sr.Manager / DGM - Sterility Assurance

1 day 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

    3 days 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

    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 : 1. Owning of Aseptic process simulation program of the site including protocol / operators and...

  • Sr.Manager / DGM - Sterility Assurance

    2 days 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 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...

  • Sr.Manager / DGM - Sterility Assurance

    2 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...

  • Sr.Manager / DGM - Sterility Assurance

    2 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...

  • Sr.Manager / DGM - Sterility Assurance

    1 day 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

    4 days 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

    3 days 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

    5 days 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...