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.
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