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Details
Senior Associate Quality for Computer Systems
Reference: | POR/525612 | Location: |
Limerick |
Qualification: | Degree | Experience: | 3-4 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
QA Analyst, QA Executive
A Senior Associate Quality for Computer Systemsis required to join a global cutting-edge biotechnology company in Limerick. You will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within this next-generation manufacturing facility. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
The Role
- Develop and maintain quality assurance procedures, policies, and systems.
- Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
- Collaborate with automation, IT and production teams to ensure quality throughout the manufacturing process.
- Investigate and address deviations, non-conformities, and CAPA to maintain quality.
- Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for systems.
- Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
- BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
- Minimum of 3 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
- Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
- Excellent problem-solving and analytical skills.
- Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus
Quality Engineering Pharmaceutical Manufacturing Executive Supply Chain Sales and Marketing Scientist Validation Engineer Chemistry Sales and Marketing Academic Scientific Life Science Microbiology Limerick Biotechnology Allied Healthcare Pharma Sales Clinical Research Dublin Cork City Packaging Engineer Medical Affairs Mayo IT Diagnostics Academic Project Manager Biopharmaceutical Laboratory Scientist Cork Supply Chain Engineering Connected Health Medical Device Quality Control Product Development Engineer PhD Quality Assurance
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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
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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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