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.
For further details please contact;Paula O’Reillyon 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie