Software Quality Assurance Manager
Our client, a leading multinational organisation based in Waterford are looking for a Software Quality Assurance Manager to join their team. The Software Quality Assurance Manager will manage Software Quality Assurance activities and resources across a regulated manufacturing facility and be responsible for facility compliance with regulatory commitments, in-house requirements and cGMPs in regards to computerized systems. This role has 3 direct reports and is to be based on-site full time. Competitive package on offer. Interviews to take place promptly so please get in touch for more details and a confidential chat.
Overview of main Responsibilities (full spec available on request):
- Development of quality systems for computer systems and support departments by means of research and assessment of current industry practices and GMP requirements
- Lead in Software Process Improvement activities
- Investigation of software related deviations as part of quality team
- Responsible for SQA review of all software related GMP critical documents, e.g. Requirement documents, software validation protocols, change controls
- Manage the Software Non Conformance process Manage the software corrective action process, perform root cause investigations, develop CAPA plans and lead software related CAPA's
- Organize and deliver training in System procedures for required personnel
- Lead and participate in risk management activities
- Participate in the site internal audit programme.
- Provision of support and assistance in execution and control of Computerised System Validation programs
- Manage validation policies
- Review of pre-delivery or vendor supplied information in regards to suitability to proceed with validation activities
- Development of protocols, test scripts and associated support documentation Perform the execution of software related protocols
- Responsible for managing the Corrective Action process in regards to individual validations to ensure follow-up and effective resolution
- Participate in team based project work and as a member of Global SQA team
What the ideal candidate looks like:
- 5+ years' experience in a similar role in a GMP regulated environment.
- 4+ years supervisory/management experience
- 3rd level qualification in software or computer related discipline.
- Qualified lead auditor
- Project management desirable
- Ability to evaluate and assess information to determine appropriate risk and required actions is critical
- Training skills are essential, with ability to lead and motivate a team.
- Ability to influence individuals and groups
- Experience of scientific report writing including such documents as SOPs, protocols, deviations, reports etc.
For a confidential discussion and more information on the role, please contact Michael O’Brien.