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Details
Sr. Associate - Quality for Computer Systems Validation
Reference: | POR/50187 | Location: |
Cork |
Qualification: | Degree | Experience: | 3-4 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Nurse Associate, QA Specialist, QA Supervisor, QA Validation Specialist, Quality Assurance Officer
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’Reillyon 087 7094141 or send CV in confidence to [email protected]
Pharmaceutical Supply Chain Medical Affairs Clinical Research Chemistry Dublin Cork City Quality Engineering Microbiology Pharma Sales Scientist Academic Engineering Laboratory Scientist Validation Engineer Limerick IT Academic Sales and Marketing Cork Quality Control Medical Device Quality Assurance Supply Chain Connected Health Biotechnology Product Development Engineer Project Manager Biopharmaceutical Sales and Marketing Scientific Diagnostics Mayo Packaging Engineer Manufacturing Executive Allied Healthcare PhD Life Science
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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