Job Description

A leading pharmaceutical company.

Responsibilities

  • Manage and continuously improve the qualification and validation system, ensuring the development and implementation of relevant procedures.
  • Ensure timely completion of qualification and validation activities for equipment, production facilities, and utility systems, including re-qualification and re-validation when required.
  • Prepare, review, and approve qualification and validation protocols and reports in compliance with GMP requirements.
  • Review and assess qualification/validation documentation prepared by external vendors prior to acceptance, ensuring compliance with company requirements.
  • Issue deviation reports during qualification/validation activities and investigate issues in collaboration with the technical team to ensure timely resolution.
  • Validate spreadsheets used by the department and perform periodic reviews of technical logbooks. ...

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