Quality Assurance Specialist

Quality Assurance Specialist voor artwork approval en SAP master data governance in een GMP-omgeving, hybride Breda.

Locatie
Breda
Sluitingsdatum

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Eisen

  • Hands-on mindset and willingness to be present on-site regularly
  • A quality-focused background with experience in QA, quality documentation review, or manufacturing quality within a regulated environment (pharma preferred; other regulated manufacturing such as food can also fit).
  • Comfortable reviewing documentation and spotting inconsistencies or risks.
  • Fluent in English (Dutch is not required).
  • Able to learn new processes and systems quickly (training will be provided for artwork review and SAP where needed).
  • Strong attention to detail, accuracy, and a compliance-minded way of working.
  • Good communication skills and the ability to collaborate with different teams.
Volledige omschrijving

Quality Assurance Specialist (Artwork & Master Data) – Breda, Noord-Brabant. Our client is a global, regulated life-sciences organization with a strong focus on quality, compliance, and patient safety. The site operates in a structured GMP environment and works closely with international stakeholders to ensure materials, data, and product information meet high regulatory standards. For our client, we are looking for a Quality Assurance Specialist to support key quality assurance activities related to artwork approval and SAP master data governance.

The Quality Assurance Artwork & Master Data Specialist will review critical information, ensure compliance, support continuous improvement, and collaborate with multiple departments to maintain robust QA systems and reliable data integrity.

Responsibilities: Perform QA review and approval of artwork for medicinal products, ensuring compliance with internal and regulatory requirements. Review and approve SAP master data activities, including critical value verification and Bill of Materials (BOM) checks. Identify, assess, and help resolve data integrity issues, discrepancies, and deviations; escalate when needed. Contribute to maintaining and improving QA systems, including monitoring performance and supporting quality metrics.

Support the creation, review, and QA approval of SOPs and Work Instructions. Participate in QA-related projects and assist with investigations as required. Build effective working relationships with stakeholders across functions (e.g., supply chain, regulatory, site SMEs, and global support teams). During onboarding, learn internal processes for artwork review and relevant SAP workflows (training is provided).

Requirements: A quality-focused background with experience in QA, quality documentation review, or manufacturing quality within a regulated environment (pharma preferred; other regulated manufacturing such as food can also fit). Strong attention to detail, accuracy, and a compliance-minded way of working. Comfortable reviewing documentation and spotting inconsistencies or risks. Good communication skills and the ability to collaborate with different teams.

Able to learn new processes and systems quickly (training will be provided for artwork review and SAP where needed). Fluent in English (Dutch is not required).

Other Information: This role requires a hands-on mindset and a willingness to be present on-site regularly, especially during the initial training period. After onboarding, the on-site presence becomes more structured with a fixed weekly on-site day and an additional flexible day.

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Quality Assurance Specialist

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