Process Validation Specialist

Company NamePolyNovo Limited Company Location Port Melbourne, Victoria, Australia

NEW Posted Date Posted 26 minutes ago Number of applicantsBe among the first 25 applicants

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Process Validation Specialist

About PolyNovo

At PolyNovo we are driven by improving the outcomes of patients through development and provision of the best surgical solutions possible.

We develop innovative medical devices utilising the patented bioabsorbable polymer technology Novosorb®.

We recently expanded our manufacturing facility and headquarters in Melbourne, establishing high-quality processes, enabling product innovation and preparing for growth.

Notable Achievements:

• ASX 200 Company
• Australian Biotech Company of the year 2019
• FDA, TGA, CE Mark (EU) registration
• We sell directly to the US, UK, Australia, NZ, and Singapore

The Opportunity

This is an exciting opportunity to join our team in the role of

Process Validation Specialist. Reporting to the Process Engineer, you will be responsible for planning, scheduling, and creating the validation of both existing and new facilities equipment and processes.

Your key duties will include, but are not limited to:

• Scheduling and executing the qualification and validation of both existing and new facilities, equipment and processes including the development and preparation of the required protocols
• Coordinate protocol approvals and produce accurate summary reports.
• Interact with and coordinate compliance efforts with other departments including: Operations, Engineering, QA, QC laboratories and R&D to provide a high degree of assurance that all qualification/validation are completed
• Participate in the Change Control processes by preparing the necessary documents and risk assessment data for approval by QA,
• Identify and implement improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes
• Review and update QMS documents such as Operating Procedures, Work Instructions and forms.
• Engage and coordinate activities of external validation and calibration contractors

Skills and Experience

• Unrestricted Australian Work Rights (i.e. Permanently with no restrictions)
• Undergraduate degree in Science, Pharmacy or Engineering
• Work experience of 3 years in a process validation, data coordinator role within a highly regulated field such as Pharmaceuticals or Medical Devices is essential
• Knowledge and understanding of cGMP regulations and practices pertaining to validation principals, manufacturing processes, quality systems, regulatory agency expectations and industry trends.
• Experience in Project Management
• Excellent written and verbal communication skills
• Strong interpersonal skills and demonstrated ability to establish and maintain effective working relationships with co-workers, suppliers and other stakeholders.

If you do not meet the above role requirements you will not be considered.

Apply!

If you have the skills, qualifications, and mindset to make this truly rare opportunity to join a leading Australian Biotech company, then click "apply" and attach your CV and Cover Letter.

We look forward to meeting you!