In-Vitro Senior Technical Analyst
ICDS Recruitment
Mayo
In-Vitro Senior Technical Analyst - Mayo. Key Purpose. Our Client is looking to recruit a Senior Technical Analyst to work in their In-Vitro (AVA) Laboratory to complete the establishment of a new suite of laboratories within a specific timeframe and to manage the laboratory once established and fully operational. The role will report to the Biosafety & Bioassay Development Manager. Key Responsibilities. Qualification and/or validation of all equipment for new AVA & Mycoplasma Laboratories in accordance with GMP and corporate validation requirement standards and guidelines. Draw up cell banking and virus stock SOPs and implement testing in strict accordance with SOP(s) ensuring full GMP regulatory compliance as appropriate. Finish qualification of all cell banks for use in AVA and Mycoplasma testing. Establishment of Test Method SOPs and validation of methods. Complete understanding off all regulatory guidelines. Generation of GMP compliant SOPs, Protocols and reports. Carrying out test method procedures. Liaise with the Quality Department for the generation of all departmental quality documents including audit responses, facility replies and deviation reports. Assist in laboratory investigations where necessary. Responsible for reporting progress information to Management. Provide technical training to team as required. Update current standard operating procedures. Generate risk assessments for laboratory and test items as required. Qualifications & Experience . BSc or MSc a relevant science discipline (e.g. Virology. A minimum of 3 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry. Experience in in-vitro bioassays and project management highly desirable. Experience in virology and biosafety testing requirements highly desirable. In-Vitro Analytical techniques essential. Knowledge of biosafety classifications and Code of Practice for the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013 (S.I. No. 572 of 2013) desirable. Ability to problem solve and work on own initiative. This job originally appeared on RecruitIreland.com.
1773 days ago