Senior Quality Assurance Professional
6 days ago
Randstad Client Solutions Ireland is seeking a highly skilled QA Specialist to join our team. This role will be responsible for ensuring the quality of our products and services in compliance with cGMP regulations.
About the Role
We are looking for a detail-oriented individual with a strong background in pharmaceutical quality and regulatory compliance. As a QA Specialist, you will be responsible for reviewing and approving batch records, assisting with QA documentation management, and providing support to Quality Control teams. You will also contribute to site training, assist in vendor management, and support internal and external audits.
Key Responsibilities:
- Review and approve batch records for Cell Culture and Purification operations to ensure cGMP compliance.
- Assist with QA documentation management, issue resolution, and efficiency metrics.
- Support change management, deviations, CAPA systems, and batch release reviews.
- Help with site risk management and maintenance of the Electronic Quality Management System.
- Provide QA support to Quality Control, including reviewing raw data, non-conformance reports, and deviations.
- Contribute to site training, deliver modules as needed, and assist in vendor management (assessments, audits, qualifications).
- Support internal and external audits, prepare Quality agreements.
- Assist with data integrity projects, equipment qualification, and setting up new electronic systems.
- Oversee product and cell bank stability programs, including sample submission and result filing.
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