CQV Specialist

Duration: Until 01/03/2025. Possible extension

Location: Valais

The scope of activities includes the coordination on the installation of equipment, drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements.

Responsibilities:

• Validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
  
• URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
  
• Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems and utilities.
  
• Write reports of completed validation activities. Work to identify efficiencies in the validation program approach.
  
• Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation.
  
• Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA's. Writing and/or revising procedures applicable to the Engineering activities.
  
• Support the Engineering group to prepare the validation, requalification, and maintenance program.
  
• Perform other duties as assigned.
  

Requirements:

• Bachelor's Degree in Science or Technical field
  
• 3-5 years of experience in pharma Industry