A new bio-pharmaceutical organisation is expanding its global manufacturing operations network with a state-of-the-art campus in Leinster. With global operations in Asia, Europe, US and China, this new Irish site will be at the forefront of their endeavours to dominate the biopharmaceutical manufacturing industry. Currently, this biopharmaceutical leader employs over 5,000 staff worldwide, and are continuing to expand their divisions.
As a key member of the QA/QV team, the Computerised Systems Quality (CSQ) Specialist will act as the Quality Representative in CSV activities on-site.
Reporting to the Associate Director for Quality responsibilities will include:
- Quality review and approval of Computer System Validation (CSV) and IT compliance documentation and associated data
- Ensure that all systems conform to relevant regulatory requirements, company specifications and standards as well as industry best practice
- Review and approve computerised system validation documentation, including; URS, FDS, Test Protocols/Reports, SOPs etc.
- BSc in Science, Engineering or related.
- 3-5 years direct Computer systems experience supporting onsite manufacturing.
- Biotech, steriles or clean room industry experience.
To discover more about this opportunity, apply now or contact Rachel Duggan at HRM on +353 1 6321870 for a confidential discussion.