QC Chemist
Pe Global
Cork
PE Global are currently recruiting for a QC Chemist – Equipment, for one of our pharmaceutical clients in Cork. It is a permanent role with a competitive salary. Essential Duties: 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. Execute laboratory equipment relocations / re-qualifications and laboratory equipment decommissioning projects as per defined roadmap. Preparation of capital justification forms (CJFs) for purchase of new laboratory equipment to meet laboratory equipment capital expenditure plans. 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. · Participation in cross functional teams. Knowledge, Experience and Skills: 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. 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. Proficiency in Microsoft Office including Microsoft Project as an added advantage. 5+ years of equipment experience and a BS degree in analytical or equivalent. Relevant experience in a pharmaceutical operations environment. If you are interested in this position, please forward your CV to tina.dorgan@peglobal.net or call 0214297900 . Alternatively please feel free to connect with me on LinkedIn. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.
2020 days ago