Key Responsibilities:
1. QMS and Regulatory Compliance:
o Implement and monitor QMS requirements at contract manufacturing sites.
o Conduct QMS and EHS gap analysis and mitigation.
o Ensure all-time GMP audit readiness and follow up on audit compliance.
o Ensure Quality events/ quality-related issues are managed timely and in a compliant way to ensure timely product release.
o Support contract sites in continuous quality improvement.
o Ensure compliance with regulatory requirements to avoid supply disruptions and punitive actions.
o Review and Maintain Quality Agreement, product specifications, artwork, Product Performance Reviews (PPR), Batch records, analytical records, Stability study documents and other GMP documents at site.
o Review and monitor Product Performance Reviews (PPR) for all products.
o Ensure audit readiness and compliance with audit findings.
o Implement CAPA arise out of different QMS events.
2. Manufacturing suppor...