Quality Assurance Associate

SIRE LIFE SCIENCES; Breda; On-site; EUR 40,000 - 60,000; Full time

Job summary

SIRE LIFE SCIENCES in Breda, Netherlands is seeking a detailed-oriented Quality Assurance Associate to review and approve master data and artwork related to medicinal products, ensuring compliance with GMP standards.

The ideal candidate will have a Bachelor’s in Life Sciences, 3 years of QA experience, and strong analytical skills. This role collaborates across departments to support continuous improvement initiatives and maintain quality integrity.

Qualifications

• Minimum of 3 years’ experience in QA or manufacturing within the pharmaceutical or medical device industry.
• Strong communication skills and fluency in English.
• Precise, organized, and detail-oriented mindset.

Responsibilities

• Review and approve SAP master data and artwork for medicinal products.
• Maintain and improve QA systems, monitoring their performance regularly.
• Collaborate with various departments to ensure quality integrity.
• Author, review, and approve operational SOPs and Work Instructions.
• Participate in QA projects and contribute to investigations.
• Screen, categorize, and resolve data integrity issues.
• Apply research and analytical skills to troubleshoot technical problems.
• Communicate potential issues proactively, supporting department goals.

Skills

Quality Assurance

GMP knowledge

Analytical skills

Communication

Education

Bachelor’s degree in Life Sciences

Master’s degree

Job description

Company

A leading global biotechnology organization dedicated to discovering, developing, and delivering innovative medicines for patients with serious illnesses. Driven by science and powered by advanced technology, the organization focuses on areas such as oncology, cardiovascular disease, inflammation, and rare diseases. Its mission is centered on improving lives by turning cutting-edge science into meaningful therapies that address unmet medical needs.

Job Description

We are seeking a detailed-oriented Quality Assurance Associate to join the team. This role is responsible for reviewing and approving critical master data and artwork related to medicinal products, maintaining QA systems, and supporting compliance with GMP standards. The ideal candidate will work closely with various departments to ensure quality integrity and support continuous improvement initiatives.

Responsibilities

• Review and approve SAP master data and artwork for medicinal products to ensure accuracy and compliance.
• Maintain and improve QA systems, monitoring their performance regularly.
• Collaborate with the Global Artwork Center, Master Data, SCPM, site SMEs, Regulatory Affairs, and QA management to ensure seamless processes.
• Author, review, and approve operational SOPs and Work Instructions related to quality assurance procedures.
• Participate in QA projects and contribute to investigations when necessary.
• Screen, categorize, and resolve data integrity issues, ensuring compliance with regulatory requirements.
• Apply research and analytical skills to troubleshoot moderate technical problems and develop effective solutions.
• Recognize escalations and communicate potential issues proactively, supporting department goals.

Requirements

• Bachelor’s degree in Life Sciences or a related field; a Master’s degree is a plus, especially as an entry-level candidate.
• Minimum of 3 years’ experience in QA or manufacturing within the pharmaceutical or medical device industry.
• Knowledge of GMP, GDP, and GCP guidelines with the ability to interpret and apply them in routine scenarios.
• Strong communication skills and fluency in English.
• Precise, organized, and detail-oriented mindset.