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Job Description
Join a global biotech company in Limerick as a Computer Systems Quality Associate to maintain quality and regulatory compliance in a brand new manufacturing facility.
This role will play a critical part in ensuring the quality of biopharmaceutical products through close collaboration with cross-functional teams.
Key Responsibilities:
- Develop and maintain quality assurance procedures, policies, and systems.
- Conduct routine self-inspections and monitoring assessments to ensure compliance with c GMP 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.
- Participate in IT and process automation organizations to provide consistency across all computer systems areas.
- Ensure compliance with periodic review, change control, deviation, backup, and archive 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.
Requirements:
- 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 c GMP, 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., Track Wise) and automation systems (e.g., DCS, Delta V) is a plus.