QA Compliance Specialist

My biopharma client is seeking a Senior Specialist, QA Compliance to join their QA team on a contract basis. This position supports supplier quality operations for a state-of-the-art biologics manufacturing site. The role reports to the Senior Manager of QA Compliance and offers an excellent opportunity to contribute to critical quality operations in a dynamic and collaborative environment.

Key Responsibilities:

• Review and approve quality agreements
• Release incoming materials for manufacturing use
• Support qualification and requalification of suppliers and materials
• Assess supplier change notifications for potential impact on qualification status
• Support material certification and direct dispense programs
• Author, review, and approve QA-related procedures
• Contribute to OpEx programs and continuous improvement initiatives
• Perform QA review, assessment, and approval activities related to:
• Change controls
• Deviations and investigations
• CAPAs
• Other relevant GMP documentation

Qualifications and Experience:

• BSc in a scientific or related discipline
• Minimum of 2 years' experience in Supplier Quality or a related QA role within the Biologics or Pharmaceutical sector
• Solid understanding of cGMP requirements and compliance expectations in a regulated manufacturing environment
• Experience with Biologics Processing is highly desirable
• Strong self-motivation and ability to work both independently and as part of a team
• Excellent communication, organizational, and time-management skills

The Next Step for you:

Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

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