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Qc Chemist - Equipment Validation

Details of the offer

QC CHEMIST III with key strengths in the area of QC Equipment Qualification and project management required for a 12 month contract in a leading Pharma company Essential Duties and Job Functions: 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 andCoordination 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. Experience : BS degree in Chemistry or equivalent and 5+ years of relevant experience in the area of QC Equipment Qualification and project management 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. Strong verbal, written, and interpersonal communication skills are required. Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs). Instrumentation skills. Skills: Validation lab Equipment Validation Validation Protocols


Nominal Salary: To be agreed

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