Quality Assurance Specialist – GMP Compliance, Breda, Noord-Brabant

Company:
Our client is a leading organization dedicated to the development and manufacturing of high-quality medicinal products. They are committed to maintaining the highest standards in their processes to ensure safety and efficacy for patients worldwide.

Job Description:
We are seeking a detail-oriented Quality Assurance Specialist to oversee GMP-related activities within the organisation. The successful candidate will play a key role in reviewing and approving essential documentation, ensuring compliance with regulatory standards, and supporting quality systems.

Responsibilities:
•    Review and approve SAP Master Data and artwork related to medicinal products.
•    Ensure QA systems are maintained, continuously improved, and properly monitored.
•    Collaborate with the Global Artwork Center, Master Data teams, and Regulatory Affairs to establish effective working relationships.
•    Lead the review and approval of operational SOPs and Work Instructions.
•    Participate in QA projects and contribute to investigations when necessary.
•    Assist in technical and regulatory problem-solving, reconciling data integrity issues, and supporting compliance within the regulatory environment.
•    Act as a resource for training and guidance within the QA team and wider organisation.

Requirements:
•    Bachelor's degree in Life Sciences or a related field; a Master’s degree is a plus.
•    Approximately 3 years of experience in Quality Assurance or manufacturing within the pharmaceutical or medical device industry.
•    Knowledge of GMP, GDP, and GCP regulations, with the ability to interpret and apply them.
•    Strong communication skills and attention to detail.
•    Fluent in English, with an accurate and meticulous approach.

Other Information:
If you are interested and want to apply, please submit your application via the apply button below and contact me.

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