Job Description

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.

📌 Quality Assurance Associate (Bachupally)
🏢 Dr. Reddy's Laboratories
📍 Bachupally