Asset Recruitment Ltd

QC Lab Analyst (BB-D9F80)

Found in: Neuvoo Irlanda

Description:
The facility has been newly acquired by the client with plans for further expansion of existing site to support company strategy to lead in biopharmaceutical manufacturing. Planning and design of the facility will commence immediately, with the aim of completing construction and commencing operations in 2023.The company, which produces biologics medicines, is one of Ireland’s leading pharmaceutical companies. The company first established in Ireland over 50 years ago and now operate across 6 sites.The Quality Control Lab Analyst will be responsible for a wide variety of testing & release activities associated with raw materials, intermediates, in process analysis and finished Active Pharmaceutical Ingredients (APIs) in the Quality Control Laboratory.Responsibilities: * Perform activities for general lab readiness, laboratory equipment qualification and method transfers. * Strong knowledge and experience of Bioassay methods. * Analytical techniques - Biochemistry WFI testing (TOC, Nitrates, Conductivity) - Compendia (Colour, Clarity, Osmolality) - Cell Biology (PCR, ELISAs, Cell based Bioassays) * Follow up-to-date analytical practices with reference specifications, regulations and industry standards. * Designing experimental study and participates in technical troubleshooting * Writing and update of SOPs. * Carry out risk assessments, inspections, audits, incident investigations * Ensure compliance with company and cGMP regulations * Cleaning and routine equipment maintenance * Full understanding of GMP requirements, ICH guidelines, EP and USP requirements and EMEA and FDA guidance's.Requirements: * 3rd level qualification in a Science, Quality or Technical field * Relevant experience (minimum 3 years) in a relevant technical role in a pharmaceutical/biotech laboratory * Demonstrate proven experience in Biochemistry WFI testing, Compendial testing, Cell Biology testing. * Have excellent interpersonal and communication skills

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