Senior Associate Quality For Computer Systems
2 weeks ago
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 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.
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 Ph D 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 c GMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
Excellent problem-solving and analytical skills.
Experience with quality management systems (e.g., Track Wise) and automation systems (e.g., DCS, Delta V) is a plus For further details please contact; Paula OReillyon or send CV in confidence to
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