QC Chemist Equipment Validation

Life Science Consultants Ltd

Cork

A QC Chemist is required for a market leading, top Ten Biopharmaceutical company based in Cork . The Cork campus specialises in Tabletting, Solid Dose, Packaging & Distribution of a range of products. The site is a strategically important site within their global operations and has grown consistently since its founding almost 15 years ago. Excellent opportunity for a QC Chemist to work to support equipment validations, equipment procurement, equipment quantification for new product introduction, ad-hoc technical investigations, IQ, OQ, PQ and vendor liaison. In this new position the QC Chemist will: Complete equipment procurement, qualification and validation of HPLC, UPLC, TOCL and dissolution baths. Perform IQs, OQs and PQs. Liaise with vendors. Generate, review and approval of validation lifecycle documentation including change controls, risk assessments, protocols, reports etc. Lead and coordinate reviews and investigations for out- of trends/out -of specifications. Troubleshoot instrumentation/test methods and associated corrective maintenance as required. Provide analytical testing status updates at governance forums. Escalate risks and implements appropriate mitigations. Timely complete of Change Controls, CAPAs, Tasks etc. Conduct GMP reviews of logbooks. Implement LEAN and 5S initiatives as required. The QC Chemist will require: A BSc degree and 2 years of relevant experience. Working knowledge of GMPs, pharmacopoeial, and regulatory requirements for analytical testing. Equipment qualification experience. Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs. Competency in the operation of Analytical Instrumentation, LIMS, Empower etc. Contact Julia at LSC on 021 4777 329 for more details on this QC Chemist role, or apply directly via this advert. This job originally appeared on RecruitIreland.com.

2763 days ago