This exciting new Senior Microbiologist role will lead and implement all microbiological services to maintain and meet all requirements for aseptic processing and filling of ACDs.
This job will involve a hand in setting up the brand new lab therefore experience in a similar start up environment will be advantageous.
- Bachelor Degree qualification in Biology or Microbiology (Masters qualification would be preferable)
- A thorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines
- 3 -5 years’ (minimum) experience in microbiology is a requirement
- Working in a sterile/aseptic/pharma environment is a distinct advantage
- Experience in supporting regulatory inspections HPRA, FDA etc is an advantage
- Experience in cleaning validation is an advantage
- Design & Set-up of new Microbiological Laboratory
- Validation and Qualification of equipment
- Vendor and stakeholder engagement
- Develop Microbiological Laboratory procedures
- Overview the Environmental Monitoring process and personnel hygiene process
- Responsible for execution of media fill runs
- Responsible for Microbiological testing of finish product
- Responsible for Microbiological monitoring of utilities
- Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements
- Carry out environmental and material microbiological tests as required.
- Define and update procedures for plant relative to microbiological and environmental monitoring
- Establish & Train laboratory staff in operational tests
- Test method transfer of microbiological method
To apply for this position please contact Amanda Reynolds at Sigmar Recruitment T: +353 91 455304 E: email@example.com
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent