ABOUT CHEMSKILL SCIENTIFIC & TECHNICAL RECRUITMENTSince ****, 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 COMPANYCS 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 OPPORTUNITYThis is an prospect 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 activitiesDeveloping, reviewing and approving validation protocols, reports, validation plans, risk assessments and associated GMP documentationPerforming and supporting Installation Qualification , Operational Qualification and Performance QualificationSupporting qualification of facilities, utilities, equipment and computerised systemsExecuting and supporting process validation, cleaning validation, requalification and ongoing validation activitiesAssessing proposed changes for their potential impact on validated systems and processesSupporting new equipment, facility and utility upgrades, process improvements and technology transfer activitiesManaging and supporting broader quality system activities, including deviations, investigations, CAPAs, change controls and risk assessmentsConducting and supporting investigations, root cause analysis and the development of appropriate corrective and preventive actionsReviewing and approving GMP and quality records to ensure compliance with internal procedures and regulatory requirementsProviding QA guidance and support to operational and technical teamsSupporting the development and maintenance of quality and validation proceduresSupporting internal audits, customer audits and regulatory inspectionsAssisting with responses to audit observations and implementation of corrective actionsIdentifying opportunities to improve quality systems, validation processes and ways of workingSupporting a culture of quality, compliance, continuous improvement and inspection readinessThe 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 YOUYou 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 disciplineA 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 activitiesExperience with the qualification and validation of facilities, utilities, equipment, processes, cleaning programs and/or computerised systemsPractical experience across broader QA and quality systems responsibilitiesExperience managing or supporting deviations, investigations, CAPAs, change controls and risk assessmentsSound understanding of GMP requirements and validation lifecycle principlesExperience conducting or supporting root cause investigations and corrective actionsStrong technical writing skills and experience preparing and reviewing GMP documentationExperience reviewing and approving quality records with a high level of accuracy and attention to detailStrong communication skills and the ability to work effectively with both technical and non-technical stakeholdersThe ability to collaborate across Engineering, Manufacturing, Technical and Quality functionsStrong organisational skills with the ability to manage multiple priorities and deadlinesExperience 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.
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📌 Senior Qa Associate – Validation (Melbourne)
🏢 CS Executive Group
📍 Melbourne