This role shall report to the In-Vitro (Cell Culture/Virology) Supervisor and the main duties & responsibilities shall be to assist the Department Manager in the following:
- Qualification and/or validation of all equipment for the new Cell Culture and Virology Laboratory in accordance with GMP and corporate validation requirement standards and guidelines.
- Draw up SOPs and implement testing in strict accordance with these SOP(s) ensuring full GMP regulatory compliance as appropriate.
- Generate and Qualify cell banks for use in client specific testing.
- Establishment of Test Method SOPs and validation of methods, where appropriate.
Core duties shall include:
- Complete understanding off all regulatory guidelines.
- Executions of Protocols and reports.
- Carrying out test method procedures.
- Assist the Department Manager and/or Supervisor in addressing all departmental quality documents including audit responses, facility replies and deviation reports.
- Assist in laboratory investigations where necessary.
- Participate in training as required.
- Update current standard operating procedures, if required.
- Assist in generation of risk assessments for laboratory and test items as required.
The following are minimum requirements related to the In Vitro Analyst position.
- BSc in a relevant science discipline (e.g. Biology, Biochemistry, etc.)
- A minimum of 1 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry is highly desirable.
- 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.
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671