Job ID :
Australia - Adelaide
- Maintaining the validation schedule and keeping all equipment and processes in a qualified state to support certification standards
- Preparation and execution of validation protocols (equipment, cleaning, computerised systems and processes)
- Assisting system owners with impact assessments and identifying qualification/validation requirements.
- Supervising all validation activities on equipment before handover/return to system owner and updating all relevant records and schedules
- Supervising technicians, fitters and contractors as required when external support is utilised for qualification activities
- Maintaining validation equipment in a state of calibration and compliance to support the company’s validation efforts
- Represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems.
- Creating/maintaining 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
- Any other task required from time to time to assist the efficient running of the Company’s business.
The successful candidate for this Validation Specialist position will have:
- 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 ability
- 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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