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CQV Specialist (m / f / d)

CQV Specialist (m / f / d)

Coopers Group AGWallis, Switzerland
Più di 30 giorni fa
Descrizione dell’offerta di lavoro

Duration : Until / / 5. 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