QASME

Provide QA oversight of manufacturing, packaging, storage and distribution activities. Ensure ongoing compliance with GMP, regulatory and company quality requirements. Conduct GMP walkthroughs, audits and compliance assessments. Lead and approve investigations, including deviations, OOS/OOT, complaints and quality incidents. Review and approve CAPAs and monitor their effectiveness. Identify and manage quality and compliance risks. Monitor and trend quality data to identify recurring issues and emerging risks. Conduct regulatory and GMP gap assessments and implement improvement plans. Support regulatory, customer and internal inspections and audits. Review and approve GMP-related change controls and assess quality and regulatory impact. Drive continuous improvement to strengthen compliance, reduce recurring quality issues and improve inspection readiness Qualification: Bachelor's Degree in Pharmacy Experience: 5–8 years' experience in a pharmaceutical manufacturing quality environment. 2–3 years' leadership experience.