Quality Assurance Associate

Supplier qualification and life cycle management

• Qualification and lifecycle management of service providers and consumable vendors
• Handling of material complaints.
• Periodic qualification of vendors and service providers by audits
• Establishment and periodic renewals of quality agreements
• To ensure timely and compliant qualification of vendors and materials used in commercial manufacturing.
• To perform periodic verification of GMP records in compliance with ALCOA principle
External manufacturing Quality assurance

• Conduct quality due diligence and qualification assessments of prospective insourcing and outsourcing partners.
• Establish, review, negotiate, and maintain Quality Agreements with external manufacturing, testing, and service partners.
• Ensure compliance with Quality Agreement commitments through periodic monitoring and governance activities.
• Receive, evaluate, approve, and track change notifications from external partners, including assessment of quality, regulatory, and supply impacts.
• Review and monitor quality events such as deviations, investigations, CAPAs, complaints, and OOS/OOT events associated with external operations.
• Perform quality risk assessments and provide GMP oversight for outsourced manufacturing and testing activities.
• Participate in audits, partner performance reviews, and inspection readiness activities.
• Maintain oversight of external partner quality performance through metrics, periodic reviews, and escalation of critical quality concerns.
• Collaborate with cross-functional teams to ensure effective management of quality systems and compliance requirements related to external manufacturing.

Function: Other
Experience Level: Mid-Senior Level