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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]
Life Science Medical Device Biotechnology Academic Sales and Marketing Validation Engineer Mayo Biopharmaceutical Dublin PhD Allied Healthcare Scientist Pharmaceutical Academic Quality Control Limerick IT Connected Health Diagnostics Clinical Research Scientific Manufacturing Executive Medical Affairs Quality Engineering Quality Assurance Cork Chemistry Engineering Project Manager Supply Chain Laboratory Scientist Cork City Sales and Marketing Pharma Sales Packaging Engineer Product Development Engineer Microbiology Supply Chain
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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
Valid XHTML - CSS