QC Technical Services, Equipment Support - Dun Laoghaire, Ireland
CK Group is recruiting for a QC Technical Services, Equipment Support to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis.
Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
The QC Technical Services, Equipment Support role will be responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities. Additionally the role will be responsible for managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo. Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems.
Key Responsibilities include:
- Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment
- Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities
- Relocation of existing equipment to new Chemistry laboratory
- Development of laboratory equipment specifications to be used for procurement of new laboratory equipment and instruments
- Writing equipment validation protocols and associated summary reports
- Maintaining a current working knowledge with regard to regulatory requirements for equipment qualification and calibration
- Coordination of equipment repairs and maintenance with vendors/contractors and also carrying out equipment maintenance as require
- Alerting Quality Control Management in the event that equipment fails to meet calibration or qualification requirements, and conducting impact assessments/investigations as required
- Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure calibration and maintenance schedules are adhered to as per CMMS Maximo.
To succeed in this role, you will have a experience in a similar role within a cGMP laboratory environment including exposure to analytical instrument validation. You will have strong knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing, an understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity and demonstrated success in managing an equipment qualification or maintenance program advantageous. Any experience with Maximo.
For more information or to apply for the QC Technical Services, Equipment Support position, please contact Natasha Young on 01246 457739 or email@example.com alternatively, please click on the link below to apply online now.
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 KA44340 in all correspondence.