The companyOur client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Holland Netherlands. They are a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on cell therapies designed to empower the immune system's ability to recognize and kill tumors.
Role descriptionAs Senior QA Specialist you are part of the Quality team, wherein you support the efforts in the exciting new area of cancer immunotherapy. You work cross functionally to assist with the development, implementation, and maintenance of a quality system for the company's first commercially marketed cell therapy product in the EU. This position is part of the European Technical Operations team that is located in Amsterdam, and you will report to the QA Manager EU.
Responsibilities• Receipt and disposition of incoming materials (if applicable).
• Review batch-related documentation, and ensures resolution of issues to release product.
• Perform preparations for product disposition/lot closure by the QP.
• Oversee the packaging and shipping process for EU.
• Oversee the product disposition process for EU.
• Ensure all product-related Deviations are initiated, investigated and resolved. Ensures that associated CAPAs are initiated and resolved, as needed.
• Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes.
• Contribute to the maintenance and reporting of metrics related to batch record review and product disposition in support of the Management Review.
• Contribute to the maintenance and reporting of Change Control metrics for Quality Systems in support of the Management Review.
• Contribute to the development and implementation of Quality on the floor processes, including batch record review.
• Intake and handling of product complaints for EU and/or related investigations.
• Liaise with manufacturing sites, supply chain and CMO’s, where applicable to facilitate smooth batch release for EU.
• Liaise with corporate quality and other quality groups to develop, implement and maintain global quality systems as well as site specific quality systems (GMP) in the EU.
• Assist in global Supplier Quality Management program.
• Assist with implementation and maintenance GMP training system in EU.
• Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
Requirements• Bachelor’s degree in the biological sciences or related field.
• Minimum of 5 years’ progressive quality or manufacturing experience in a pharmaceutical, biotech, or biologics operation
• Working knowledge and ability to apply GMPs in conformance to US and EU standards
• Demonstrated ability to train staff
Other informationAre you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.