- Perform and review a range of techniques such as immunoassays, cell-based potency bioassays and aseptic techniques as part of routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.
- Work as directed by the Bioassay Manager / Associate Director, according to Company safety policies, cGMP and cGLP.
- Required to drive compliance with our Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Required to comply with our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Ensure that all Quality Systems within the department are adhered to on a daily basis.
- Operate as part of the QC team performing the allocated testing and laboratory-based duties.
- Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
- Knowledge of cGMP
- Laboratory Quality Systems experience
