Job Description

JOB DESCRIPTION

  • Establish Qualification approach for complex equipment and process. Ensure establishment of Global Qualification standard for equipment/system in SUN formulation site (Drug Product).
  • Establish Global SOP for various system to optimize the validation practices, usage and cost implicated on qualification.
  • Establish Qualification strategy for Greenfield and Brownfield projects.
  • Resolve issue escalated from sites pertaining to equipment qualification , GMP process and sterility assurance.
  • Establish Qualification strategy for Process control system.
  • GMP Audit support with respect to Audit readiness, Response.
  • Develop capability of Equipment qualification team.
  • Mentor Qualification leads and SMEs across regions.
  • To centrally organize, guide, control the qualification and validation programmed of each site.
  • Plan for impr...

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