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Qualification & Validation Associate

Switzerland   •  Contract/Temporary, Full time


CK QLS are recruiting for a Qualification & Validation Associate to join an important project with a global pharmaceutical Company at their site based in Basel on a contract basis for 6 months with possibility of an extension.

The main purpose of the role will be to:
· Support equipment cleaning and sterilization processes verification / validation
· Support function ensuring compliance of manufacturing environment (Clean class A, B, C, areas)
· Support equipment acquisition from writing User requirement specification to qualification execution for equipment and utilities (HVAC, Compressed air, Water For Injection, Filling line, autoclave, Rabs, inspection cabinets...)
· Establish preventive maintenance plans for equipment and utilities
· Write and update Standard Operating Procedures
· Trouble shooting and investigations in line with cGMP relevant documentation (management of deviations or change controls or CAPAs)
· Coordination of supplier activities including planning, execution and report of activities performed by suppliers of equipment and utilities.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
· Bachelor\'s degree with minimum 5 years of working experience in qualification of facilities, utilities and equipment (HVAC, clean rooms) for sterile environment
· Experience in equipment cleaning/ sterilization processes validation, risk assessment
· Expert in Good Manufacturing Practices
· Advanced knowledge in liquid filling (syringes and vials) or aseptic production and aseptic practices
· Advance knowledge in maintenance and engineering for production lines
· Knowledge in automations and Computerized systems
· Languages: fluent English both written and spoken, German and French are advantages
· Team spirit, good communication skills and ability to work with multi-disciplinary team including external suppliers and scientists
· Willingness to work in sterile environment (with respective clothing, hygiene and behavior requirements for grade A and B)

Please could you send any correspondence in English. Please quote reference 50991 in all correspondence.


You MUST be eligible to work in Switzerland. Learn more

  • Agency: CK Group
  • Contact: Adrien Guimard
  • Phone: 01438 723 500
  • Reference: 50991
  • Posted: 28th June 2021
  • Expires: 26th July 2021

CK Group

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