Senior QA Associate — Validation & Quality Systems

CS Executive Group; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

CS Executive Group seeks a Senior QA Associate – Validation for an established Australian pharmaceutical manufacturer in Melbourne. You will own validation deliverables across facilities, utilities, equipment, processes, cleaning programs and computerised systems in a GMP setting.

The role requires hands-on validation experience, a science/engineering degree and a strong QA mindset to support the broader Quality Management System and regulatory inspections.

Qualifications

• A Bachelor’s Degree in Science, Engineering or a related discipline.
• A minimum of 5+ years’ experience in a GMP-regulated pharmaceutical, nutraceutical, medical device or similar environment.
• Demonstrated hands-on experience planning, executing, reviewing and approving qualification and validation activities.
• Experience with qualification and validation of facilities, utilities, equipment, processes, cleaning programs and/or computerised systems.
• Strong QA and quality systems responsibilities across a GMP environment.
• Experience managing deviations, investigations, CAPAs, change controls and risk assessments.
• Sound understanding of GMP requirements and validation lifecycle principles.
• Strong technical writing and GMP documentation skills.
• Ability to collaborate across Engineering, Manufacturing, Technical and Quality functions.

Responsibilities

• Plan, coordinate, execute, review and approve qualification and validation activities.
• Develop, review and approve validation protocols, reports, validation plans and risk assessments.
• Perform IQ, OQ and PQ and support qualification of facilities, utilities, equipment and CSV.
• Support validation of processes, cleaning, equipment upgrades and technology transfer.
• Review GMP and quality records to ensure compliance with procedures and regulatory requirements.
• Provide QA guidance to operational and technical teams.
• Support internal and customer audits and regulatory inspections.

Skills

Quality Assurance

Validation

GMP

Documentation

Root Cause Investigation

CAPA

Change Controls

Risk Assessments

Cross-functional Collaboration

Communication Skills

Education

Bachelor’s Degree in Science/Engineering

Tools

CSV (Computerised Systems Validation)

Job description

CS Executive Group seeks a Senior QA Associate – Validation for an established Australian pharmaceutical manufacturer in Melbourne. You will own validation deliverables across facilities, utilities, equipment, processes, cleaning programs and computerised systems in a GMP setting.

The role requires hands-on validation experience, a science/engineering degree and a strong QA mindset to support the broader Quality Management System and regulatory inspections.