Description
Role Responsibilities:- Development of Validation Plans, Cycle Development, Process Qualifications (PQs), Requalification Protocols and System Summary reports for Autoclaves, Steam in Place Sytems and Controllled Temperature Chambers.
- Prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards.
- Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
- Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards Review and Approve validation protocols and assessments from a quality system documentation perspective.
- Participate as required in project activities.
Basic Qualifications:
- Bachelor of Science/Engineering degree or equivalent.
- Knowledge of cGMP's and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills
- A third level qualification in Science, Engineering or a relevant Quality discipline.
- Understanding of the use of BIs and Thermal Mapping to demonstrate system sterility.
If you would like to hear more about this position or are interested in applying please call Sarah Irvine on or reply with your most recent CV. Or alternatively if you know of anyone who may be available please get in touch as we offer shopping vouchers for any successful referrals.