RQs of Utilities (WFI) Process RQs (SIP, Bulk Sterilization, Autoclave) Cleaning validation Warehouse mapping Filtration skids Mixing tank Washer qualification Trending of Results Data mining LIMS queries
Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
Lead project validation activities, and provide basic guidance and direction to junior project engineer as required.
Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.
Manage qualification execution and lead validation deviation investigation encountered in qualification.
Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities.
Able to manage cross function stakeholders, and to lead / facilitate meeting ...