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
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