CQV Engineer (m/w/d)

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Job Detail

  • Job-ID 301301

Job-Beschreibung

Your responsibilities:

  • Validation activities: Facilities, Utilities, Validation Life Cycle,
  • Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
  • The validation documentation deliverables include 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.
  • 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.

Your background:

  • Bachelor in Science or Technical field.
  • Advanced Level Pharma Industry 5-10 years.
  • Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner.
  • Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.

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