Sr Associate Supplier Quality

Role Description

Working independently, the individual will be responsible for, but not limited to the following:

• Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation
• Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
• Collaborate with raw material suppliers to ensure alignment to quality agreements, identifying performance improvement opportunities
• Understand and incorporate risk management strategy into the overall raw material lifecycle
• Provide support to the supplier periodic monitoring overs...