Senior QA Commercial Quality

Proclinical; Sydney; Hybride; AUD 70 000 - 100 000; Plein temps

Résumé du poste

Proclinical is seeking a Quality Assurance Associate to support quality operations for affiliates in Australia and New Zealand. This role focuses on ensuring GMP/GDP compliance and maintaining robust quality systems across markets.

You will manage regulatory requirements, audits, and inspections, and act as a bridge between local and global teams to uphold product safety and high standards. Responsibilities include coordinating QMS alignment with global directives, overseeing GDP/GMP training,

Qualifications

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

Responsabilités

• Coordinate and align local 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.

Connaissances

Quality management

Regulatory compliance

Communication skills

Remote collaboration

English fluency

Formation

Pharmacy degree

Life sciences degree

Description du poste

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 role focuses on ensuring compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and internal quality standards. You will play a key role in maintaining quality systems, managing regulatory requirements, and supporting audits and inspections.

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.