Senior Commissioning, Qualification Expert

3 days ago

Singapore beBeeCqv Full time

Job Title: Senior Commissioning, Qualification Expert

We are seeking an experienced professional to lead our commissioning and qualification efforts. As a CQV expert, you will plan, coordinate, and execute the validation of computer systems, equipment, and analytical instruments.

Key Responsibilities:

  • Commissioning and Qualification: Develop and execute commissioning and qualification plans for manufacturing process equipment, package units, analytical instruments, freezers, and other related systems.
  • Validation Execution: Conduct FAT, SAT, IQ, OQ, PQ of equipment and analytical instruments according to internal procedures and industry standards.
  • Lifecycle Management: Create, review, and approve equipment qualification and analytical instruments lifecycle documentations, including protocols and reports, risk assessments, and technical specifications.
  • Investigations: Lead investigations into discrepancies identified during qualification activities.

Requirements:

  • Experience: Relevant experience in validation activities, including creation, execution, and review of validation lifecycle documents.
  • Leadership Skills: Leadership skills in daily validation meetings with cross-functional teams to resolve validation issues.
  • Equipment Qualification: Experience in equipment qualification, including analytical instrumentation and manufacturing equipment.
  • Industry Knowledge: Work experience in Pharmaceutical or BioPharma industries.
  • Validation Execution: Hands-on validation execution experience.
  • Cleanroom Environment: Able to work in a cGMP environment, including cleanrooms or technical areas.

We value candidates with relevant experience in validation activities, leadership skills, and expertise in equipment qualification. If you have a strong background in the Life Sciences industry, please submit your application.

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