Software Quality Assurance Manager

Information Technology
Information Technology

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.


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Your Consultant
Michael O'Brien
Cork Branch Manager