Sr. Associate
4 hours ago
Sr. Associate - Quality for Computer Systems Validation
A Computer Systems Quality Sr. Associate 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 our 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.
Key Responsibilities:
- 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.
- Participate in IT and process automation organizations to provide consistency across all computer systems areas.
- Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for systems.
- Develop common local procedures for Computer systems and help the site consistently interpret and implement global policies across all computer systems areas.
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.
- Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
- Excellent problem-solving and analytical skills.
- Detail-oriented with a strong commitment to maintaining high-quality standards.
- Effective communication and teamwork skills.
- 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’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie
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