Orion Group Life Sciences are looking for a Quality Control Chemist on behalf of our Biopharmaceutical client located in Cork. Initial 12 month contract. Responsibilities: 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.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 GTrack 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.Requirements and skills: QC Chemist required for the Cork QC lab.5+ years of relevant experience and a BS degree in Chemistry or equivalent.Relevant experience in a pharmaceutical operations environment.Proficiency in Microsoft Office including Microsoft Project as an added advantage.Key strengths in the area of QC equipment qualification and project management is highly desirable.Working knowledge of GMPs, pharmacopoeia, 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 computerized systems.Instrumentation skills.Detail orientation and problem solving skills for root cause analysis.Organizational skills for concurrent execution of multiple laboratory equipment qualifications and projects.Ability to work in an agile environment and be flexible to meet business priorities.
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