Senior Associate Quality for Computer Systems
Senior Associate Quality for Computer Systems
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A Senior Associate Quality for Computer Systems is 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.
The Person
* 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.
* Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus
* Excellent problem-solving and analytical skills.
For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance and Information Technology
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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