Join a pioneering biotechnology company known for its groundbreaking work in oncology and immunology. They're looking for a Quality Officer for a six-month project focused on advanced therapies. This role involves ensuring product quality and compliance in production, managing documentation, and releasing products under strict GMP standards. Be a vital link across manufacturing and supply chain operations, with chances to enhance quality systems and drive process improvements. Continue reading to see why we could be the perfect match for you.

Over het bedrijf

Oxford Global Resources

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About the Client

Our client is a fast-growing biotechnology company dedicated to developing next-generation therapies that transform patients' lives. With state-of-the-art facilities across Europe and the U.S., they combine science, innovation, and technology to deliver breakthrough treatments in oncology and immunology. The site hosting this project focuses on advanced therapy medicinal products (ATMPs) and operates under stringent GMP standards to ensure the highest level of product quality and patient safety.

Job Description

We are seeking a Quality Officer to support GMP manufacturing activities on a six-month project. The role focuses on maintaining product quality and compliance across ATMP production, documentation, and release processes. You will act as a key QA representative across manufacturing, supply chain, and SAP-related operations, ensuring adherence to regulatory standards and continuous improvement of quality systems.

Responsibilities

Review and approve manufacturing batch records
Oversee deviations, CAPAs, and change controls to ensure full GMP compliance
Act as QA representative for manufacturing and supply chain activities
Support review and release of products within SAP, maintaining complete audit trails
Manage QA documentation related to products, logistics, and quality events
Approve and maintain SOPs and procedures within assigned functional areas
Participate in quality investigations and provide recommendations for improvement
Identify opportunities for process efficiency and continuous improvement initiatives

Requirements

Degree in Biology, Biotechnology, Chemistry, or related life sciences discipline
3-5 years' experience in a GMP-regulated quality assurance or manufacturing role
Hands-on experience with ATMP, biologics, or pharmaceutical production preferred
Strong working knowledge of cGMP documentation and QA systems
Experience managing deviations, CAPAs, and change control processes
Familiarity with SAP and electronic quality systems desirable

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