QA IT Specialist

Competitive
Contract
Tipperary
13 Sep 2019
BBBH741545

Will provide QA IT oversight and support for the site computerised systems to ensure compliance

QA IT Specialist- Pharmaceuticals- South East

Job Purpose:

The successful candidate will provide QA IT oversight and support for the site computerised systems to ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. This will include supporting implementation of new automated equipment and a DCS on a key site project.

Key Responsibilities:

  • Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports.
  • Providing independent quality review and approval of system changes.
  • Supporting and approving computerised systems investigations and deviations.
  • Ensuring consistent approach to qualification, change and deviation management across systems.
  • Providing timely and pro-active QA IT support and guidance to facilitate project timelines.

Experience:

  • Min. 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
  • Working knowledge of relevant regulations and industry standards.
  • Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
  • Excellent communication skills.
  • Project management experience will be an advantage.
  • DeltaV experience will be an advantage.

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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