Qc Equipment Validation Specialist

4 weeks ago

Dublin, Ireland Lsc, Life Science Consultants Full time

Role overview
LSC, Life Science Consultants has a 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.
Applicants with 3+ years of experience working in the pharmaceutical or biotechnology industry are encouraged to consider this opportunity.
Key responsibilities
Conduct periodic reviews of instrument validation as part of the validation life cycle.
Alert Quality Control Management when equipment fails to meet calibration or qualification requirements and conduct impact assessments/investigations as required.
Schedule and coordinate equipment repairs and maintenance with vendors/contractors, minimizing downtime for lab equipment and disruption to laboratory activities.
Participate in technical project teams as a subject matter expert on instrument validation regulations and procedures.
Own and project manage change controls and adherence to Change Control metrics where applicable.
Support and manage the addition of project components to CMMA Maximo.
Act as a key contributor and sponsor to Data Integrity Assessments for laboratory systems.
About you
Detailed knowledge of the methodology, 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 is advantageous.
Visa and eligibility
Applicants within the pharmaceutical sector in Ireland are required to have a Stamp 1G or Stamp 4 visa.
We are unable to provide visa sponsorship.
Thank you for your understanding.
Application and contact
Apply via this advert or contact Cian Marnane at LSC on if you have any questions about this opportunity.
Details
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Engineering and Science
Industries: Pharmaceutical Manufacturing
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