Job Description
We are seeking a highly skilled and experienced Qualification Engineer to support our site requalification program. This is a key role in ensuring the on-going validation and compliance of existing and new equipment, systems, and processes at our facility.
* Coordinate designing, executing, and reporting on periodic qualification programs for equipment, systems, and processes.
* Designing, executing, and reporting on periodic requalification studies for equipment, systems, processess. Ensure these studies are managed in conjunction with all required standards (Health & Safety regulations).
* Provide technical interpretation guidance of current US FDA EU validation requirements (aseptic processing lyophilisation sterilisation dehydrogenation)
* Evaluate ensure that the validation status of equipment systems are compliant cGMP at all times. Participation external regulatory inspections necessary