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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