Job Description
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Based in the Southeast suburbs of Melbourne
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Monday to Friday, full time hours
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Plan, coordinate, execute, review, and approve qualification and validation activities
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Develop, review, and approve qualification and validation documentation, including protocols, reports, risk assessments, validation plans, and associated records.
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Perform qualification activities for facilities, utilities, equipment, and computerized systems, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
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Participate in the management of quality system processes, including deviations, investigations, CAPAs, change controls, and risk assessments
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Support the development, review, and maintenance of quality and validation procedures
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Support internal audits, customer audits, and regulatory inspections
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Identify opportunities to improve quality systems, validation processes, and ways of working.
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Promote a culture of quality, compliance, continuous improvement, and inspection readiness throughout the organisation About you:
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Tertiary education in Science, Engineering or Pharmaceutical Science
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Minimum of 3 years' experience working within a GMP-regulated
pharmaceutical,complementary
medicines, nutraceutical, medical device, or other regulated manufacturing environment
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Must have robust experience in sterile processing and pharmaceutical manufacturing
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Problem solving, creative thinking, and effective decision-making skills
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Excellent communication skills, detail oriented and team collaboration.
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Experience with qualification and validation of facilities, utilities,
equipment,processes,
cleaning programs, and/or computerized systems
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bout the role:
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Pharmaceutical company
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Based in the Southeast suburbs of Melbourne
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Permanent Opportunity
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Monday to Friday, full time hours
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About your duties:
n
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Plan, coordinate, execute, review, and approve qualification and validation activities
n
Develop, review, and approve qualification and validation documentation, including protocols, reports, risk assessments, validation plans, and associated records.
n
Perform qualification activities for facilities, utilities, equipment, and computerized systems, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
n
Participate in the management of quality system processes, including deviations, investigations, CAPAs, change controls, and risk assessments
n
Support the development, review, and maintenance of quality and validation procedures
n
Support internal audits, customer audits, and regulatory inspections
n
Identify opportunities to improve quality systems, validation processes, and ways of working.
n
Promote a culture of quality, compliance, continuous improvement, and inspection readiness throughout the organisation About you:
n
Tertiary education in Science, Engineering or Pharmaceutical Science
n
Minimum of 3 years' experience working within a GMP-regulated
pharmaceutical,complementary
medicines, nutraceutical, medical device, or other regulated manufacturing environment
n
Must have strong experience in sterile processing and pharmaceutical manufacturing
n
Problem solving, creative thinking, and effective decision-making skills
n
Excellent communication skills, detail oriented and team collaboration.
n
Experience with qualification and validation of facilities, utilities,
equipment,processes,
cleaning programs, and/or computerized systems
n

📌 Quality Validation Associate (Victoria)
🏢 Evolve Scientific
📍 Victoria