We have an exciting opportunity for a QA Specialist to join an expanding team in Dublin to help support the Quality Operations unit.
In this key QA position, you'll take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards. You'll collaborate across departments, manage critical QMS responsibilities, and contribute to continuous improvement initiatives.
Key Responsibilities and Duties:
- Conducts various activities to ensure adherence to relevant regulatory requirements.
- Supports the investigation of customer complaints related to manufacturing processes.
- Identifies deviations from standard practices, evaluates their impact, and determines corrective actions.
- Reviews and approves GMP deviation investigations and CAPAs.
- Conducts internal audits and walkthroughs on behalf of the QA department to ensure GMP site compliance.
- Contributes to Strategic, Technical, and Operational Excellence projects for the site on behalf of QA, and represents QA in cross-functional meetings.
- Works independently on routine tasks, requiring minimal guidance, and receives general direction on new assignments.
Education and Experience:
- To Bachelors Degree in a scientific/technical discipline required
- A minimum of 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
