Join a global company in their pharma business within a growing Quality team Manage validation activities including cleaning, process equipment validation Lead investigations, CAPAs, deviations quality systems COMPANY Our client is an established pharmaceutical manufacturing business located in Melbourne's south-east , producing and packaging a broad range of therapeutic products within a highly regulated GMP environment.
The business works with recognised pharmaceutical and healthcare organisations and has a strong focus on quality, compliance and continuous improvement.
As part of its continued investment in Quality, the business is now seeking experienced professionals to join its growing Quality team.
Our client offers full relocation assistance for interstate applicants.
THE ROLES Senior Quality Associate – Permanent Full Time Reporting to the Quality Manager, this position will play a key role in maintaining and continuously improving APM's Pharmaceutical Quality System and ensuring ongoing compliance with GMP, TGA and applicable regulatory requirements.
Key responsibilities will include: Manage key quality systems including deviations, CAPAs, change controls, document control and customer complaints Lead investigations into non-conformances using root cause analysis and risk-based decision-making Coordinate internal and supplier audits and support customer audits and regulatory inspections Review batch documentation and support batch disposition and product release activities Monitor quality performance, identify trends and drive continuous improvement and ongoing inspection readiness Quality Associate – Validation – Permanent Full Time This position will provide Quality Assurance oversight across APM's qualification and validation activities, ensuring manufacturing facilities, utilities, equipment, processes, cleaning programs and computerised systems remain in a validated state.
Key responsibilities will include: Plan, coordinate,



execute, review and approve qualification and validation activities Develop and review validation documentation including protocols, reports, validation plans and risk assessments Support qualification of facilities, utilities and manufacturing equipment, including IQ, OQ and PQ Execute and support process validation, cleaning validation, requalification and ongoing validation activities Work cross-functionally on new equipment, facility and utility upgrades, process improvements and technology transfer projects ABOUT YOU Senior Quality Associate To be considered for the Senior Quality Associate position, you will ideally bring: A tertiary qualification in Science, Pharmacy, Chemistry, Microbiology, Chemical Engineering or a related discipline A minimum of 5 years' Quality Assurance experience within a GMP-regulated pharmaceutical or therapeutic manufacturing environment Strong knowledge of GMP, TGA, PIC/S and Pharmaceutical Quality Systems Demonstrated experience managing deviations, CAPAs, change controls, investigations, document control and complaints Experience supporting internal, customer and regulatory audits , combined with strong root cause analysis and quality risk management capability Quality Associate – Validation To be considered for the Validation position, you will ideally bring: A tertiary qualification in Science, Engineering or a related discipline A minimum of 5 years' experience within GMP-regulated pharmaceutical, complementary medicines, nutraceutical,



medical device or other regulated manufacturing Demonstrated experience planning, executing, reviewing and/or approving qualification and validation activities Practical experience across equipment/facility qualification, process validation and cleaning validation , with CSV experience highly regarded Sound knowledge of GMP and validation lifecycle principles , together with experience in quality systems such as deviations, investigations, CAPAs, change controls and risk assessments Both positions require Quality professionals who are comfortable working within a fast-paced manufacturing environment, can operate with a high degree of autonomy and enjoy working collaboratively across Quality, Manufacturing, Engineering and Technical teams.
If you are an experienced Quality professional looking to join an established pharmaceutical manufacturing operation and contribute to the ongoing development of its Quality and Validation systems, we would welcome your application.
HOW TO APPLY To apply, please submit your resume in Word format via SEEK.
For a confidential discussion regarding either opportunity, please contact Jo at CS Executive Group .
THANK YOU Given we appreciate the effort it requires to express an interest in response to a job advert, we would like to thank you in advance for taking the time to apply for this role.
Unfortunately, due to the large volume of applications we receive daily, we typically only make contact with individuals whom we consider to have suitable qualifications and experience to be assessed further for shortlisting.
Nevertheless, all resumes submitted to CS Executive Group are retained on our database—you might therefore be contacted by us for suitable roles arising in the future.
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📌 Senior Qa Roles – Pharmaceuticals (Victoria)
🏢 CS Executive Group
📍 Victoria