GMP Quality Assurance Specialist – Clinical Supply Chain, Breda, Noord-Brabant

Company Overview:
A leading global biotechnology organization committed to improving patient lives through innovative medicines. The company fosters a values-driven culture, emphasizing scientific excellence, collaboration, and continuous development. With a rich history of pioneering breakthroughs, it offers a stimulating work environment where passionate professionals can grow and make an impact.

Job Description:
We are seeking a dedicated GMP Quality Assurance Specialist to oversee the quality aspects of the clinical supply chain. In this role, you will ensure compliance with GMP standards for investigational medicinal products used in clinical trials, supporting the manufacturing, labeling, and distribution processes to ensure product integrity and regulatory adherence.

Responsibilities:

• Provide QA oversight for the supply, labeling, and distribution of clinical trial products.
• Review and approve batch documentation to support the certification process, ensuring compliance with EU and international regulations.
• Approve clinical label artwork, ensuring accuracy and regulatory compliance.
• Assess temperature excursions during transport and at clinical sites, addressing deviations appropriately.
• Support investigations related to manufacturing, transport, and quality issues with a focus on continuous improvement.
• Review and approve minor deviations, ensuring procedural compliance and proper documentation.
• Develop, review, and update operational SOPs and work instructions to maintain quality standards.
• Prepare and analyze monthly quality metrics to monitor and report on processes.
• Collaborate across departments, including manufacturing, quality, clinical research, and regulatory affairs, to resolve quality issues swiftly.
• Support clinical packaging and labeling operations on the shop floor via batch checks, record reviews, and issue investigations.

Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, or related field.
• Approximately 3 years of experience in Quality Assurance within the pharmaceutical or medical device industries, including batch record review and investigations.
• Solid knowledge of GMP, GDP, and GCP standards.
• Fluency in English.

Other Information:
If you are interested and want to apply, please submit your application via the apply button below and contact me.
This opportunity is ideal for professionals passionate about quality assurance in clinical manufacturing, eager to work in a collaborative, innovative environment. Applicants should reside in the Netherlands or live within commuting distance of Breda, in line with our relocation policies.

56007