Quality Validation Associate
Evolve Scientific • Melbourne, AU
10 days ago
Job description
- Based in the Southeast suburbs of Melbourne
- Monday to Friday, full time hours
- 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
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
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