Kelly Services are seeking a Senior In Vitro (Cell Culture/Virology) Analyst to work in and help to establish a new Cell culture/Virology Laboratory wih a client located in Ballina, Co. Mayo, Ireland.
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 new Cell culture/Virology Laboratory in accordance with GMP and corporate validation requirement standards and guidelines.
- Draw up SOPs and implement testing in strict accordance with SOP(s) ensuring full GMP regulatory compliance as appropriate.
- Generate cell banks and viral stocks for use in specific client testing.
- Establishment of Test Method SOPs and validation of methods, where appropriate.
Core duties shall include:
- 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.
The following are minimum requirements related to the Senior In Vitro Analyst position.
- BSc or MSc a relevant science discipline (e.g. Biology, Biochemistry, etc.)
- 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 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.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.