Reference Code
CK3016

Our Pharmaceutical client is seeking to recruit a Laboratory IT/Automation QA Specialist for a contract role based on site in Tipperary.

If successful, you will provide independent oversight and support for lab computerized systems to ensure compliance with regulatory and company requirements. The ideal candidate will be degree qualified with at least 5 years’ relevant experience in an IT QA/CSV/or similar role in the Pharmaceutical industry.

 

Essential Functions of the Role:

  • Provide IT QA support for laboratory systems' projects across various business units
  • Ensure lab automation systems' compliance with CSV, SDLC, Cyber Security and Data Integrity requirements
  • Support day-to-day activities such as system changes, investigations, periodic reviews and upgrades
  • Provide independent quality review and approval of system development lifecyle (SDLC) documentation, such as plans, requirements, risk assessments, protocols and reports
  • Provide independent quality review and approval of system changes
  • Support and approve computerized systems investigations and deviations
  • Ensure a consistent approach to qualification, change and deviation management across systems and projects 
  • Provide timely and pro-active IT QA support and guidance to facilitate project timelines

You will have a third level degree in a relevant discipline and will ideally have:

  • 5 years' experience in a similar role in the pharmaceutical industry
  • Experience with computerized laboratory instruments and automation systems
  • Working knowledge of relevant regulations and industry standards, including current data integrity expectations and best practices
  • Proven ability to meet timelines, prioritize tasks and engage with stakeholders
  • Excellent inter-personal skills and a proven ability to work collaboratively with all levels of the organization
  • Good communication and time management skills
  • Self-starter and decision maker

What you will get:

Attractive remuneration, while working in a multi-disciplinary environment, in a vibrant expanding international company

 

Please Note

All CV’s are treated in the strictest confidence.
Recruitment agencies need not apply.

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Do you have what it takes ?

Laboratory IT / Automation QA Specialist CK3016 - CK3016

Co Tipperary, Ireland

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