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Job ID :
50441BR
Location :
Australia - Adelaide
:
Job Description


The Validation Specialist will support manufacturing by ensuring all aspects of validation such as equipment and facilities qualification, routine re-qualification activities, cleaning validation, computerized systems validation and process validation are complete and up to date and in line with required standards.



Key Responsibilities:

  • Maintain the validation schedule and keeping all equipment and processes in a qualified state to support certification standards.
  • Preparation and execution of validation protocols.
  • Assist system owners with impact assessments and identifying qualification/validation requirements.
  • Supervise all validation activities on equipment before handover/return to system owner and updating all relevant records and schedules.
  • Supervise technicians, fitters and contractors as required when external support is utilized for qualification activities.
  • Maintain validation equipment in a state of calibration and compliance to support the company‚Äôs validation efforts.
  • Represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems.
  • Create/maintain qualification related records, procedures, documents and drawings.
  • Ensuring compliance with health and safety (EHS) legislation.
  • Engaging with project teams to help with selection, installation and commissioning of new equipment.


Minimum Requirements/Qualifications:
  • Validation experience within a GMP environment.
  • Demonstrable validation experience in a medical device ISO13485, biopharmaceutical, consumer healthcare or related industry.
  • Demonstrated understanding of validation requirements for international markets including (but not limited to) FDA and EMA.
  • Knowledge of commissioning and equipment validation to include autoclaves, temperature controlled storage and automated production lines, cleaning validation experience.
  • Proven problem solving skills/diagnosing faults/resolving qualification issues.
  • Excellent planning and time management skills.
  • The ability to adapt to rapid changes in project priorities and meeting aggressive timelines
  • The ability to work independently and autonomously to support validation projects and communicate progress and any issues via team meetings and project meetings.


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