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Details
Senior Associate - Quality Assurance (MES)
Reference: | POR/425373 | Location: |
Limerick |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
A Senior Associate – Quality Assurance (MES) 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. 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 (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) 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 (Corrective and Preventive Actions) to maintain quality associated with MES quality events.
- Participate in IT, production, and process automation organizations to provide consistency across all manufacturing execution systems.
The Person
- BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
- 3+ years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
- Knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
- Excellent communication, problem-solving and analytical skills.
- Detail-oriented with a strong commitment to maintaining high-quality standards.
- Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus.
Project Manager Supply Chain Quality Engineering Chemistry Sales and Marketing PhD Pharmaceutical Manufacturing Executive Quality Control Cork Academic Microbiology Laboratory Scientist Quality Assurance Dublin Sales and Marketing Life Science Medical Device IT Packaging Engineer Diagnostics Clinical Research Validation Engineer Allied Healthcare Product Development Engineer Scientific Academic Mayo Limerick Pharma Sales Engineering Supply Chain Medical Affairs Cork City Connected Health Scientist Biopharmaceutical Biotechnology
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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