CK Group is recruiting for a QA IT Specialist to join a company in the Pharmaceutical industry at their site based in Brinny on a contract basis for 11 months.
Our client has a long history of pushing the boundaries of science in order to help fight some the worlds most urgent global health challenges. This role is based at a state of the art biologics operation where they formulate and fill vaccines and biologic products.
The role, will be working at our clients site in Brinny which is situated in Cork in South West Ireland. The site is just 30 minutes drive from the centre of Cork and is accessible by bus too.
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. The QA IT specialist will focus on supporting the DI remediation of the laboratory equipment. Additional responsibilities will include supporting day-to-day activities, such as system changes, investigations and periodic reviews, and multiple system upgrades across various business units.
• 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 and projects.
• Providing timely and pro-active QA IT support and guidance to facilitate project timelines.
• Liaising with the Data Integrity Champion to ensure compliance with the regulatory and company DI expectations.
• Where required, engaging with QA IT specialists from other sites, central validation groups and other internal organisations to ensure consistent application of SDLC and DI standards and procedures.
• Min. 5 years of experience in QA IT/CSV, CSV, laboratory systems engineering and/or a similar role in the pharmaceutical industry.
• Working knowledge of relevant regulations and industry standards, including current data integrity expectations and best practices.
• Experience with a wide range of laboratory systems.
• Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
• Excellent communication skills.
• Project management experience will be an advantage.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46427 in all correspondence