LSC have a great contract opportunity for a QC Equipment Validation Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 3+ years of experience
working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
* 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.
* Where applicable, owns and project manages change controls and adherence to Change Control metrics
* Supporting and managing the addition of project components to CMMA Maximo
* Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems
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.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Sarina Abdulha on 0
if you have any more questions about this opportunity