Pharmaceutical Validation Specialist

2 weeks ago


Sydney, New South Wales, Australia beBeeValidation Full time $95,000 - $125,000
Pharmaceutical Validation Expertise

This role offers an exciting opportunity to contribute to the validation program, ensuring the maintained validated state of facilities, utilities, equipment, IT infrastructure, devices and compounding processes.

  • Coordinate activities of assigned personnel to ensure quality of completed work.
  • Manage development, implementation, and execution of validation protocols and procedures.
  • Interface with suppliers/vendors to address documentation and compliance issues.
  • Prepare documentation for regulatory submissions/audits and present validations during inspections.
  • Execute validation protocols and prepare reports.
  • Maintain the validated state through proper change management.
  • Ensure filing and documentation are up-to-date and compliant with standard processes.

Requirements:

  • Bachelor's Degree in a scientific or related field.
  • Five years' experience in a similar position is essential.
  • Experience in developing, executing, monitoring, and managing validation activities.
  • Process validation experience is highly regarded.
  • Demonstrated knowledge of qualification and validation requirements within the pharmaceutical industry.
  • Proven time management skills.
  • Ability to solve problems effectively and independently.
  • Excellent communication and report writing skills.

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