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.