QC Instrumentation Validation Specialist
Westbourne IT Global Services is a transglobal organisation currently with Delivery Centres in Auckland, Cork and Foster City. Our business strategy is to significantly grow and expand our business over the next 2 - 3 years through a combination of organic growth and acquisitions. Our core differentiator is our ability to deliver scalable and world class 24*7 technical helpdesks. Our target market is a combination of Fortune 500 clients and high growth companies in the pharma, life sciences and IOT/manufacturing sectors. We have built our established reputation with an impressive list of long-standing clients because of our unique culture. This culture places innovation, problem solving, people engagement and trust at the heart of our company. Our mission is to be a global leader in innovative IT customer support solutions that meet and exceed our business partner’s requirements.
We are looking to hire a QC Instrumentation Validation Specialist based in Cork, Ireland.
- Support the QC Support Team Lead in coordinating and supervising all the equipment maintenance and qualification activities.
- Support the qualification of new equipment from sourcing through execution (IQ/OQ/PQ) and final implementation
- Provide training to the other QC analysts when required
- Promote compliance on Health, Safety and Environment in the QC Group in conjunction with QC team leads
- Assist with audits/investigations as required
- Generation/Reporting of key performance indicators for the group
- To support the QC Support Team Lead in the development of areas of expertise in analytical testing in order to solve problems.
- Interaction with other departments e.g. QA, Technical Services, Production.
- Liaising with internal and external customers in relation to QC/BU issues
- Replace the QC Support Team Lead whenever requested or in case of absence
- Ad hoc duties as determined by QC Management Team
- Perform or review performance qualification (PQ) activities for laboratory systems
Required Experience / Skills:
- 3 plus years’ experience in QC or equivalent experience such Engineering Operations
- Experience working in an HPRA/FDA regulated environment is essential
- Result driven, team player, able to deal with multiple projects/tasks
- Demonstrated problem solving, initiative and decision-making skills
- Knowledge and experience in cGMP environment
- Experience leading/participation in project-based initiatives.
- Experience in cGMP's and HSE rules
- Flexibility is important (willingness to work additional hours or weekends as required by business needs)
- Technical ability in laboratory systems.
- Previous experience in equipment qualification/calibration activities
- Knowledge and hands-on experience in Analytical Chemistry, and QC procedures.
- University, or equivalent, degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar Chemistry/ Health Sciences fields.