A QC Specialist III is required on an initial 12-Month basis by CareerWise Recruitment for our Cork-based multinational research-based pharmaceutical Company. Key strengths in the area of QC equipment qualification and project management is highly desirable. THE ROLE: 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: 5+ years of relevant experience and a BS degree in Chemistry or equivalent. Relevant experience in a pharmaceutical operations environment. Working knowledge of GMPs, pharmacopoeial and regulatory requirements for laboratory equipment qualification and analytical testing. 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. Proficiency in Microsoft Office including Microsoft Project as an added advantage Please call Aisling OHagan-Yil today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: QMS Reg PM
