Develop and execute operational readiness plans, including testing, documentation, and training, to ensure new capacity is fully operational upon integration.
Handle escalated enquiries and appeals from the public and training providers relating to courses, including conducting inquiries to ascertain non-compliances against SWDA’s Terms and Conditions for Registered Training Providers (RTPs).
Serve as escalation owner for critical supplier quality issues, including supply disruptions, major nonconformances, and regulatory findings tied to suppliers.
Ensure, through training and verification, the appropriate use of current documentation, as well as the use of good documentation practices during all the stages of manufacturing.
Act as secondary contact for Pharmacovigilance activities, monitoring post‑marketing surveillance, adverse events, product complaints, recalls, and field safety corrective actions, while supporting investigations, deviations and CAPAs.
Containment & Disposition – responsible on quality event containment scoping, risk assessment, material disposition (including coordinate Material Review Board (MRB)) and production recovery.
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