Senior QA Commercial Quality (Male) / Senior QA Commercial Quality (Female)

Quality Assurance Associate Opportunity

Are you driven to uphold the highest standards in commercial quality? Step into this role where your expertise ensures operational integrity and supports the delivery of safe, effective treatments worldwide. Proclinical is seeking a Quality Assurance Associate to support quality operations for affiliates in Australia and New Zealand. This position emphasizes compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and internal quality standards.

Key Responsibilities

• Coordinate and align local Quality Management Systems (QMS) with global directives and in-country requirements.
• Oversee GMP/GDP training programs and provide regular compliance reports to management.
• Manage documentation systems for local procedures and handle deviations, CAPAs, and change controls.
• Maintain wholesaler and dealer licenses for Australia and New Zealand, ensuring compliance with regulatory requirements.
• Approve suppliers, customers, and subcontracted activities impacting GDP.
• Perform secondary product release for the Australian and New Zealand markets.
• Support health authority inspections and audits, including readiness preparation, coordination, and follow-up actions.
• Act as deputy coordinator for product recalls and manage mock recall exercises.
• Provide quality support for technical product complaints and counterfeit investigations.
• Conduct temperature excursion assessments and support new product launches.

Key Skills and Requirements

• Degree in Pharmacy or Life Sciences.
• Experience in commercial quality within the biotech or pharmaceutical industry.
• Knowledge of Responsible Person duties in Australia and New Zealand.
• Familiarity with Good Distribution Practices (GDP) and quality management systems.
• Strong communication and organizational skills.
• Ability to work remotely and collaborate effectively with global and local teams.
• Fluency in English.

If you are interested in this exciting opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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