15556 - Quality Control Chemist III

at  ORION

Job description

• 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