IT Quality Assurance - Carlow, Ireland
Posted on Apr 13, 2019 by Anonymous
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.
The main purpose of the role will be to provide IT compliance/validation support to the Team to ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity.
Further responsibilities will include:
· 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.
· A proven background in CSV / IT QA within the pharmaceutical sector.
· Degree qualified or equivalent in a related subject.
· Experience with MDD, FDA CFR and MHRA regulations is preferred.
· DeltaV 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 45291 in all correspondence