Key Responsibilities
* Ensuring qualification and validation compliance for equipment, infrastructure and computerized systems across aseptic drug product CAPEX projects
* Reviewing and approving SOPs, URS documentation, validation plans, protocols and reports, including CQV and CSV records
* Providing QA oversight, guidance and decision-making on qualification and validation matters for project teams and external vendors
* Acting as the primary QA contact for lifecycle management of qualified systems and for documentation within global platforms such as Kneat, Trackwise and DMS
* Managing quality deviations, change controls and CAPAs, ensuring timely closure and appropriate escalation when needed