Due to the substantial increase in our business, we are currently looking for a Quality Assurance Specialist, to join our team of consultants.
- Supports creation and implementation of the aseptic operator training program for the site
- Creation and update of procedures and risk assessments
- Ensures adherence to global procedures and standards
- Creation of SOPs in the area of aseptic processing (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
- Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
- Supports Annex 1 Gap mitigation and remediation in collaboration with the manufacturing department (e.g. creation of work instructions, risk assessments, process design
