Quality Assurance - IT - County Tipperary
CK Group is recruiting for a Quality Assurance (IT) contractor to join a company in the Pharmaceutical industry at their site based in Carlow, Ireland on a contract basis for 12 months.
Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. This position sits within their Manufacturing Division, which consists of a team of dedicated, energetic individuals, committed to being the most trusted supplier of pharmaceuticals and health products worldwide. They have an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
This role will be working at the Ballydine site which exports to more than 30 countries, including Japan, the US and much of Europe. It produces active pharmaceutical ingredients (APIs) for use by subsidiaries throughout the world, including late stage clinical APIs. The site includes a formulation, R&D and manufacturing facility, which supports our clients initiative to bring new medicines to market more effectively. It develops innovative ways to formulate new products from pilot to commercial scale, and supplies tablets for late stage clinical trials, launch and early stage supply.
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.
- 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.
To be considered for the role you should have the following skills, knowledge and experience:
- Previous 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.
- Infrastructure, OSI PI and PAS-X experience will be an advantage.
For more information or to apply for this position, please contact Jenni on 01438 768 710 or firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. 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 45446 in all correspondence.