QA IT CSV Consultant

Summary:

The successful candidate will join the site QA IT team to provide independent 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 day-to-day activities, such as system changes, investigations and periodic reviews, and multiple system upgrades across various business units.

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.
• Where required, engaging with QA IT teams from other sites to standardise and align approach to computerised systems compliance.

Experience:

• Extensive 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.
• Project management experience will be an advantage.
• Infrastructure, OSI PI and PAS-X experience will be an advantage.

To apply:

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 2039288385 or email me on: tgardner@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!