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Barden are delighted to be supporting our Global Biopharmaceutical client in their search for QC Equipment Specialist for their Cork facility.
ABOUT THE ROLE:
- The QC Equipment Specialist must have key strengths in the areas of equipment qualification and project management.
Key Responsibilities:
- Execution of IQ/OQ/PQ protocols for laboratory equipment e.g. HPLC, UPLC, Dissolution Systems, GC etc.
- Generation, review and approval of Laboratory Equipment Qualification lifecycle documentation including change controls, risk assessments, protocols, reports etc.
- Generation of ERES assessments, operational procedures, PM/CAL procedures and schedules.
- Co-ordinate vendor activities and Coordination and scheduling of laboratory equipment vendors to support PM/CAL of laboratory equipment.
- Troubleshoot instrumentation/test methods and associated Corrective Maintenance.
- Provision of Equipment Qualification status updates at governance forums.
- Escalation of risks and implementation of appropriate mitigations.
- Perform system administrator duties for stand-alone laboratory equipment e.g. method setup, account creation etc.
- Perform system periodic reviews for existing laboratory equipment as per defined schedules.
- Coordinate planning, organization, and implementation of laboratory equipment projects within specified objectives.
- Lead and coordinate investigations involving deviations from governing procedures and processes.
- Timely completion of assigned change controls, CAPAs and tasks.
- Implement LEAN and 5S initiatives as required.
- Participation in the QC Operational Excellence program.
- Assist in the training of QC staff as needed.
ABOUT THE PERSON:
Skills & Expertise:
- Strong knowledge of Data Integrity & CSV including 21CFRPart 11/ Annex 11 requirements for laboratory computerised systems.
- Working knowledge of GMPs, pharmacopoeial, and regulatory requirements for laboratory equipment qualification and analytical testing.
- Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
Typical Education & Experience
- 5+ years of relevant experience and a BS degree in Chemistry or equivalent.
- Relevant experience in a pharmaceutical operations environment.
Hi, we’re Barden. We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Life Sciences, Legal, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions.Simple.
