QC Equipment Validation Specialist

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 Cian Marnane at LSC on if you have any more questions about this opportunity!