Third Party Manufacturer QA Sr.Associate (TPM QA )
Core
Ensure quality and compliance performance of assigned Third Party Manufacturers (TPMs) for pharmaceutical products, managing audits, investigations, and quality agreements.
Role type
Senior IC Quality Assurance Associate (Pharmaceutical Manufacturing)
Builds
Quality oversight and compliance for external manufacturing partners
Domain
Healthcare / Pharmaceuticals / Quality Assurance
Required skills
cGMP compliance, quality risk management, deviation investigation, change control, CAPA management, GMP audits, supplier qualification, regulatory inspection support, cross-functional collaboration, technical documentation review
Preferred skills
Pharmaceutical manufacturing processes, validation/qualification activities, stability programs, product release support, GEMBA visits
Technologies
Microsoft Office
Responsibilities
Accountable for quality and compliance performance of assigned Third Party Manufacturers (TPMs), ensuring compliance with applicable regulations, cGMP requirements, Abbott Global/Regional Policies, and Quality Technical Agreements (QTAs). Responsible for quality risk management activities including deviations, investigations, change controls, CAPAs, product complaints, Product Quality Reviews (PQRs), stability programs, validation activities, and product release support. Review and approve TPMs quality documentation including Batch Manufacturing Records, Packaging Records, Validation Protocols and Reports, Stability Protocols and Reports, PQRs, change controls, deviations, investigations, exceptions, and CAPAs. Lead quality oversight of TPMs through performance monitoring, quality metrics review, GEMBA visits, remediation plans, and continuous improvement initiatives. Lead and coordinate quality activities related to GMP audits, supplier qualification, regulatory inspections, technology transfers, new product introductions, and cross-functional projects. Drive investigation, resolution, and escalation of quality and compliance issues, providing risk-based recommendations and support to internal stakeholders and senior management. Manage the preparation, approval, maintenance, and periodic renewal of Quality Technical Agreements (QTAs) and support the maintenance of the Approved Supplier List.
Seniority
Senior, hands-on IC
