CK Group is recruiting for a QA IT Specialist to join a company in the Pharmaceutical industry at their site based in Carlow on a contract basis for 11 months and has a hourly rate of €62.42.
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.
The role is based at our client's site in Carlow, Ireland. Carlow is a fascinating town which pre dates written Irish history, has played a major part in Irish history and even served as the capital of the country in the 14th century. Carlow is located approximately 50 miles from Dublin and has good rail links as well as being close to the N9 & N80 roads.
The successful candidate will join the QA IT team to provide independent oversight and support for the computerised systems being implemented and modified as part of the site expansion project 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 support a number of shopfloor system, including DeltaV, PLC/SCADA systems, OSI PI and MES.
- Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports for new and modified systems.
- Providing independent quality review and approval of system changes.
- Supporting and approving computerised systems investigations and test deviations.
- Ensuring consistent approach to qualification, change and deviation management across systems being implemented on the project.
- 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.
- Min. 5 years of 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.
- DeltaV, PLC/SCADA, OSI PI and PAS-X 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 46955 in all correspondence