Your new company

Your new role

• Generation, review and approval of Laboratory Equipment Qualification lifecycle documentation including change controls, risk assessments, protocols, reports etc.
• Execution of IQ/OQ/PQ protocols for laboratory equipment e.g. HPLC, UPLC, Dissolution Systems, GC 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.

What you'll need to succeed

• Working knowledge of GMPs, pharmacopoeial, and regulatory requirements for laboratory equipment qualification and analytical testing.
• Strong verbal, written, and interpersonal communication skills are required.
• Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
• Strong knowledge of Data Integrity & CSV including 21CFRPart 11/ Annex 11 requirements for laboratory computerised systems

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.