Quality Assurance Specialist
SIRE® Life Sciences
Quality Assurance Specialist
Samenvatting
Wat krijg je?
Wat ga je doen?
- Artwork voor medicinale producten goedkeuren
- SAP masterdata en stuklijsten controleren
- Data-integriteitsfouten en afwijkingen oplossen
- Kwaliteitssystemen en metrics continu verbeteren
- SOP's en werkinstructies opstellen
Wat verwachten wij?
- Experience in QA within a regulated environment
- Experience with SAP master data and BOM checks
- Experience resolving data integrity issues and deviations
- Experience reviewing and approving SOPs and instructions
Volledige vacaturetekst
At this global life-sciences organization, you play a vital role in ensuring patient safety by overseeing artwork approval and SAP master data governance. You will collaborate with international stakeholders to maintain high regulatory standards in a structured GMP environment. The company offers a modern hybrid working model with fixed on-site days, allowing you to balance teamwork with focused execution. Dive into this specialized QA world and help safeguard product integrity from the very first glance.
Company
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.
Job Description
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.
59200
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