This leading biopharmaceutical CDMO are continuing to expand their Irish operation by establishing a new state-of-the-art facility in north Leinster. A vacancy has now arisen for a Computerised Systems Quality Specialist (CSV) to join a dynamic and high performing team. This site will manufacture for global supply and is expanding in response to growing customer requirements.

Based within the QA department the Computerised System Quality Specialist will act as the Computer Systems Quality representative in support of Computerised System Validation (CSV) activities executed on site. This is initially a 12 month contract with a competitive hourly rate.

The Role

Essential duties and responsibilities of the Computerised Systems Quality Specialist will include:

• Quality review and approval of Computer System Validation (CSV) and IT compliance documentation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
• 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.
• Participate in software, equipment and instrument qualification where necessary.
• Participate in event/deviation investigation and change evaluation during qualification, to ensure the systems, software and equipment meet quality and compliance requirements prior to release.
• Responsible for ensuring that all manufacturing processes, QC and Enterprise systems perform and operate as per their design.
• Work with all personnel, contractors and visitors to ensure that all safety policies, procedures and regulations are fully adhered to across the site on an ongoing basis.

The Person

You will have skills and experience in the following:

• BSc and strong experience in a Quality Engineering/Quality Assurance role for Biologics, medical device or pharmaceutical manufacturing.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices
• Ability to operate across functional boundaries, both internal and external
• Demonstrated knowledge of GxP regulations (e.g. EU-GMP, FDA, ISO)
• Good understanding of the principles of Computerised System Validation
• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
• Prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
• Critical thinking skills

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.