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Details
Senior Associate Quality Operations
Reference: | POR/185144 | Location: |
Limerick |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
QA Specialist
A Senior Associate Quality Operations is required to join a global biotech company based in Limerick. This role will be fully on site in a brand new start of the art manufacturing facility and will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products.
The role
- Work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
- Develop and maintain quality assurance procedures, policies, and systems
- Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations
- Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality
- Maintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports
The Person
- BSc Hons, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline
- Minimum of 5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment
- Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements
- Experience with quality management systems (e.g., TrackWise, MES) is a plus
For further details please contact;Paula O’Reillyon 087 7094141 or send CV in confidence to [email protected]
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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