Quality Validation Associate

Evolve Scientific; City of Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

Evolve Scientific is seeking a qualified validation specialist based in the Southeast suburbs of Melbourne to plan, coordinate and drive qualification and validation activities across facilities, utilities, equipment, and computerized systems. You will develop protocols, reviews, and reports to support GMP-compliant operations.

The role emphasizes quality system management, audits, and continuous improvement.

Qualifications

• Tertiary education in Science, Engineering or Pharmaceutical Science.
• Minimum of 3 years’ experience in a GMP-regulated pharmaceutical, complementary medicines, nutraceutical, medical device, or other regulated manufacturing environment.
• 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.

Responsibilities

• 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 records.
• Perform qualification activities for facilities, utilities, equipment, and computerized systems (IQ/OQ/PQ).
• Participate in quality system processes including deviations, investigations, CAPAs, change controls, and risk assessments.
• Support development, review, and maintenance of quality and validation procedures.
• Support internal and 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.

Skills

Problem solving

Creative thinking

Decision making

Communication skills

Attention to detail

Team collaboration

Education

Tertiary education in Science/Engineering/Pharmaceutical Science

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