Product Quality Representative

Proclinical Group; Sydney; On-site; AUD 90,000 - 120,000; Full time

Job summary

Proclinical Group in Sydney, Australia seeks a Product Quality Representative to oversee and maintain quality systems for supply chain management and distribution. The role ensures GMP, GDP, and GDP compliance with external partners and supports product release, temperature excursion evaluations, and quality assessments.

The role collaborates across cross-functional teams on new projects, implements LSP initiatives, and maintains SOPs and quality agreements with warehouses and third‑party

Qualifications

• A university degree in Pharmacy, Life Sciences, or an equivalent field.
• Knowledge of GMP and GDP regulations.
• Proficiency in Microsoft Office; experience with Veeva Quality Doc, QMS systems, and SAP is preferred.

Responsibilities

• Maintain and oversee the product supply chain quality system in compliance with global standards and local regulations.
• Implement and manage new logistics service provider (LSP) projects, including warehouse change control and follow-up activities.
• Develop and update local Standard Operating Procedures (SOPs) related to external warehouse and product supply management.
• Prepare and manage quality agreements with warehouses and third‑party operators handling product distribution.
• Conduct regular verification and documentation of distributor license validity.
• Review and release finished products for distribution, ensuring compliance with required documentation and inspections.
• Manage product release processes in SAP and address internal distribution complaints when necessary.
• Assess and resolve product issues related to temperature excursions.
• Coordinate new product launches, discontinuations, and divestitures.
• Provide quality input on supply chain events or deviations and ensure corrective actions are completed.
• Act as a backup for the Quality Manager and Recall Coordinator to ensure business continuity.
• Manage administrative tasks such as record retention, archiving, and conducting regular business continuity plan (BCP) tests.

Job description

Are you passionate about quality and precision? Join our client in this product quality position and help ensure top-tier standards every day.

Proclinical is seeking a Product Quality Representative to oversee and maintain quality systems for supply chain management and distribution. This role involves ensuring compliance with Good Manufacturing Practices (GMP), Good Wholesaling Practices (GWP), and Good Distribution Practices (GDP). You will play a key role in product batch release, temperature excursion evaluations, and quality assessments of external partners. The position also requires collaboration with cross-functional teams to support new projects and ensure seamless operations.

Responsibilities:

• Maintain and oversee the product supply chain quality system in compliance with global standards and local regulations.
• Implement and manage new logistics service provider (LSP) projects, including warehouse change control and follow-up activities.
• Develop and update local Standard Operating Procedures (SOPs) related to external warehouse and product supply management.
• Prepare and manage quality agreements with warehouses and third‑party operators handling product distribution.
• Conduct regular verification and documentation of distributor license validity.
• Review and release finished products for distribution, ensuring compliance with required documentation and inspections.
• Manage product release processes in SAP and address internal distribution complaints when necessary.
• Assess and resolve product issues related to temperature excursions.
• Coordinate new product launches, discontinuations, and divestitures.
• Provide quality input on supply chain events or deviations and ensure corrective actions are completed.
• Act as a backup for the Quality Manager and Recall Coordinator to ensure business continuity.
• Manage administrative tasks such as record retention, archiving, and conducting regular business continuity plan (BCP) tests.

Key Skills and Requirements:

• A university degree in Pharmacy, Life Sciences, or an equivalent field.
• Knowledge of GMP and GDP regulations.
• Proficiency in Microsoft Office; experience with Veeva Quality Doc, QMS systems, and SAP is preferred.
• Strong leadership, communication, and interpersonal skills.
• Ability to train and collaborate with cross-functional teams and external partners.
• Effective problem‑solving, negotiation, and time management abilities.
• Agile mindset with a sense of urgency and the ability to prioritize tasks.
• Familiarity with pharmaceutical industry regulations.