Senior QA Associate – Validation

CS Executive Group; 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

ABOUT CHEMSKILL SCIENTIFIC & TECHNICAL RECRUITMENT

Since 1988, ChemSkill Scientific & Technical Recruitment has been one of Australia's longest-established specialist scientific and technical recruitment consultancies.

We partner with organisations across the pharmaceutical, chemical, manufacturing, food, biotechnology and industrial sectors, recruiting for scientific, engineering, technical and quality-focused roles throughout Australia.

With almost four decades of specialist experience, we provide permanent recruitment and contract/labour hire solutions, connecting talented people with outstanding career opportunities across Australia.

THE COMPANY

CS Executive Group has been engaged to recruit a Senior QA Associate – Validation for an established manufacturer operating within a highly regulated GMP environment.

Our client is an established Australian pharmaceutical manufacturer specialising in the development and manufacture of high-quality TGA products within a highly regulated environment. The business combines specialist pharmaceutical manufacturing expertise with a strong focus on quality, compliance and continuous improvement. As part of a large and diversified Australian manufacturing group, employees benefit from the stability, resources and broader opportunities of a major organisation while working within a specialised pharmaceutical operation.

THE OPPORTUNITY

This is an opportunity for an experienced QA professional to take ownership of validation deliverables while maintaining broad exposure across Quality Assurance and quality systems.

A key focus of the position is maintaining the validated state of manufacturing facilities, utilities, equipment, processes, cleaning programs and computerised systems in accordance with applicable GMP requirements, regulatory expectations and internal quality standards.

Importantly, the position extends beyond validation. You will be expected to actively support the wider Quality Management System and provide practical QA oversight across the business.

Reporting to the Quality Manager, your responsibilities will include:

• Planning, coordinating, executing, reviewing and approving qualification and validation activities
• Developing, reviewing and approving validation protocols, reports, validation plans, risk assessments and associated GMP documentation
• Performing and supporting Installation Qualification , Operational Qualification and Performance Qualification
• Supporting qualification of facilities, utilities, equipment and computerised systems
• Executing and supporting process validation, cleaning validation, requalification and ongoing validation activities
• Assessing proposed changes for their potential impact on validated systems and processes
• Supporting new equipment, facility and utility upgrades, process improvements and technology transfer activities
• Managing and supporting broader quality system activities, including deviations, investigations, CAPAs, change controls and risk assessments
• Conducting and supporting investigations, root cause analysis and the development of appropriate corrective and preventive actions
• Reviewing and approving GMP and quality records to ensure compliance with internal procedures and regulatory requirements
• Providing QA guidance and support to operational and technical teams
• Supporting the development and maintenance of quality and validation procedures
• Supporting internal audits, customer audits and regulatory inspections
• Assisting with responses to audit observations and implementation of corrective actions
• Identifying opportunities to improve quality systems, validation processes and ways of working
• Supporting a culture of quality, compliance, continuous improvement and inspection readiness

The role works extensively across the organisation, partnering with Engineering, Manufacturing, Technical Teams and Quality Control to ensure validation and broader QA requirements are effectively integrated into operational activities.

ABOUT YOU

You will be an experienced Quality Assurance professional with hands-on validation expertise and broader Quality Management System experience within a GMP-regulated manufacturing environment.

Ideally, you will bring:

• A Bachelor’s Degree in Science, Engineering or a related discipline
• A minimum of 5 years’ experience within a GMP-regulated pharmaceutical, complementary medicines, nutraceutical, medical device or similar environment.
• Demonstrated hands‑on experience planning, executing, reviewing and approving qualification and validation activities
• Experience with the qualification and validation of facilities, utilities, equipment, processes, cleaning programs and/or computerised systems
• Practical experience across broader QA and quality systems responsibilities
• Experience managing or supporting deviations, investigations, CAPAs, change controls and risk assessments
• Sound understanding of GMP requirements and validation lifecycle principles
• Experience conducting or supporting root cause investigations and corrective actions
• Strong technical writing skills and experience preparing and reviewing GMP documentation
• Experience reviewing and approving quality records with a high level of accuracy and attention to detail
• Strong communication skills and the ability to work effectively with both technical and non-technical stakeholders
• The ability to collaborate across Engineering, Manufacturing, Technical and Quality functions
• Strong organisational skills with the ability to manage multiple priorities and deadlines
• Experience with computerised systems validation (CSV), regulatory inspections, customer audits, capital projects, facility upgrades or technology transfer would also be advantageous.

The ideal candidate will be comfortable taking validation deliverables from planning through to completion while remaining actively involved in the broader day‑to‑day responsibilities of Quality Assurance.