GMP QA Lead – Validation & Quality Systems

Cs Executive Group; Victoria; On-site; AUD 110,000 - 150,000; Full time

Job summary

CS Executive Group has been engaged to recruit a Senior QA Associate – Validation for an established Australian pharmaceutical manufacturer operating in a highly regulated GMP environment. The role focuses on ownership of validation deliverables while supporting broader QA and quality systems across the business.

You will work with Engineering, Manufacturing, Technical Teams and Quality Control to integrate validation with day-to-day operations, ensuring continued compliance and inspection

Qualifications

• Bachelor’s degree in Science, Engineering or related discipline.
• Minimum of 5 years’ experience in GMP-regulated environments (pharma, nutraceutical, medical device or similar).
• Hands-on experience planning, executing, reviewing and approving qualification/validation activities.
• Experience with facilities, utilities, equipment, processes, cleaning programs and/or computerised systems validation.
• Experience across broader QA and quality systems responsibilities.
• Experience managing deviations, investigations, CAPAs, change controls and risk assessments.

Responsibilities

• Plan, coordinate, execute, review and approve qualification and validation activities.
• Develop, review and approve validation protocols, reports and GMP documentation.
• Perform Installation Qualification, Operational Qualification and Performance Qualification.
• Support qualification of facilities, utilities, equipment and computerised systems.
• Execute and support process, cleaning validation and requalification.
• Assess proposed changes for impact on validated systems and processes.
• Support upgrades, process improvements and technology transfer.
• Manage deviations, investigations, CAPAs, change controls and risk assessments within the quality systems.
• Conduct investigations and root cause analyses, implement corrective actions.
• Review GMP and quality records for compliance and accuracy.
• Provide QA guidance to operational and technical teams.
• Develop and maintain quality and validation procedures.
• Support internal and customer audits and regulatory inspections.

Skills

QA expertise

Validation

GMP compliance

Root cause analysis

Technical writing

Cross-functional collaboration

CAPA management

Education

Bachelor’s Degree in Science/Engineering

Tools

CSV (Computerised Systems Validation)

Job description

CS Executive Group has been engaged to recruit a Senior QA Associate – Validation for an established Australian pharmaceutical manufacturer operating in a highly regulated GMP environment. The role focuses on ownership of validation deliverables while supporting broader QA and quality systems across the business.

You will work with Engineering, Manufacturing, Technical Teams and Quality Control to integrate validation with day-to-day operations, ensuring continued compliance and inspection