Adventitious (Ava) In-Vitro Laboratory S

CPL

Mayo

On behalf of my client, a global company specializing in pre-clinical and clinical laboratory services for the pharmaceutical, medical device and biotechnology industries, I am recruiting for an Adventitious (AVA) In-vitro Laboratory Supervisor. In this role you will join the Biologics Department and you will report to the Biosafety & Bioassay Development Manager. Responsibilities of the role include the following: Ensure all equipment is qualified and/or validated 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. Assist Virologist in establishment of Test Method SOPs and validation of methods. Complete understanding off all regulatory guidelines. Prepare costings for all test methods. Day to day operation of the laboratory area:Scheduling of staff. Scheduling of tests. Ordering consumables. Stocking of laboratories. Revenue Recognition. Ensure strict adherence to health & safety practices in the laboratory. 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. Responsible for leading 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. Candidates with the following background and experience are invited to apply: PhD in a relevant science discipline (e.g. Virology. A minimum of 5 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry. Experience in assay development and ICH analytical validation. Experience in in-vitro bioassays and project management highly desirable. Experience in virology and biosafety testing requirements highly desirable. Analytical techniques essential. Ability to project manage multiple studies. 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. Ability to problem solve and work on own initiative. For more information and to apply for this role please call Deirdre on +353 1 2784671 or e-mail dbolger@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671. This job originally appeared on RecruitIreland.com.

1825 days ago