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 setting
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- Must have strong 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:

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