Issuance of QAQC Non-compliance to sub-contractors
Attend monthly QAQC presentation and meeting at Corporate QAQC Department
Conduct regular inspections to ensure works are in compliance with method statements (in accordance to BCA’s Good Industry Practice & approval from the clients and consultants)...
Able to perform risk assessments to determine validation scope and ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and other relevant guidelines.
Handle validation deliverables for new global system implementations, infrastructure upgrades, operational optimization, and required periodic reviews of existing automated GxP platforms.
Involve actively as a CSV engineer for global implementation projects such as ERP, MES, eQMS, eVal projects and review/approve/provide valuable feedback to project teams and external vendors....