Quality Validation Associate
- Plan, execute, review and approve qualification and validation activities and documentation across facilities, utilities, equipment, processes and computerised systems.
- Manage quality system activities including deviations, investigations, CAPAs, change controls and risk assessments, and support audits and regulatory inspections.
- Bring at least three years’ experience in a regulated manufacturing environment, with strong sterile processing and pharmaceutical manufacturing experience.
bout the role:
- Pharmaceutical company
- Based in the Southeast suburbs of Melbourne
- Permanent Opportunity
- Monday to Friday, full time hours
About your duties:
- Plan, coordinate, execute, review, and approve qualification and validation activities
- Develop, review, and approve qualification and validation documentation, including protocols, reports, risk assessments, validation plans, and associated records.
- Perform qualification activities for facilities, utilities, equipment, and computerized systems, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Participate in the management of quality system processes, including deviations, investigations, CAPAs, change controls, and risk assessments
- Support the development, review, and maintenance of quality and validation procedures
- Support internal audits, customer audits, and regulatory inspections
- Identify opportunities to improve quality systems, validation processes, and ways of working.
- Promote a culture of quality, compliance, continuous improvement, and inspection readiness throughout the organisation
About you:
- Tertiary education in Science, Engineering or Pharmaceutical Science
- Minimum of 3 years’ experience working within a GMP-regulated pharmaceutical,complementary medicines, nutraceutical, medical device, or other regulated manufacturing environment
- Must have strong experience in sterile processing and pharmaceutical manufacturing
- Problem solving, creative thinking, and effective decision-making skills
- Excellent communication skills, detail oriented and team collaboration.
- Experience with qualification and validation of facilities, utilities, equipment,processes, cleaning programs, and/or computerized systems
Apply!
If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed).
Or, if you have any questions, please contact Deborah on ************.
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
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