LSC have a great contract opportunity for a Sr Associate QC to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation.
- Planning, executing, and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.
- Conduct periodic reviews of instrument validation as part of validation life cycle.
- Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
- Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.
- Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing.
- Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
- Demonstrated success in managing an equipment qualification or maintenance program advantageous.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Alison Jones at +353 214771329 if you have any more questions about this opportunity!