Description
We are looking for a
Validation Supervisor (m/f)
Reference: -en
Start: 01/17
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Coordination and supervision of Performance qualification activities and Process Validation activities on site at CMO
- Review and support development of the qualification and validation documentation
- Ensure the activities are executed according to the companies standards
- Tracking qualification and validation timeline and alignment with overall project plan, timely reporting of issues to the team
- PQ on rooms and utilities: HVAC & clean rooms, SCADA, sterile gases (nitrogen, compressed air), deep freezing rooms and cold rooms
- Process Implementation and Validation: freeze-thaw cycle implementation, freeze drying cycle implementation, aseptic process validation – media-fill, sterile drug product manufacturing process validation, visual inspection process for media-fill vials, visual inspection process for lyophilized product
Your qualifications
- Experience in qualification of utilities and equipment for sterile drug product manufacturing
- Experience in process validation for sterile drug product manufacturing
- Good GMP knowledge, knowledge of international standards for qualification, process validation, practical experience in risk management, change control management, deviations management, environmental monitoring
- Ability to organize and work with people on various levels at CMO site
- Fluency in English, Russian of advantage
Skills:
- Qualification/validation specialist