Quality Assurance Specialist (GMP)

Sire Search; Breda; On-site; EUR 42,000 - 60,000; Full time

Job summary

Sire Search is seeking a detail-oriented Quality Assurance Specialist with a GMP background to join a leading life sciences organization in the Netherlands. The role focuses on reviewing artwork and master data to ensure compliance and quality.

This temporary position offers onsite training for 3-4 days, followed by 2 days per week, with a six-month contract and potential for longer-term employment. English fluency is required; Dutch is a plus.

Qualifications

• Bachelor's degree or higher in Life Sciences or related field.
• Approximately 3 years of QA or manufacturing experience in pharmaceutical or medical device industry.
• Strong understanding of GMP, GDP, and GCP regulations.
• Fluent in English; Dutch language skills are a plus but not mandatory.
• Willing to commit to an initial six-month contract with no immediate guarantee of permanent employment.
• Willing to work onsite for 3-4 days during training and 2 days afterwards; preference for candidates near Breda.

Responsibilities

• Quality reviews of artwork and associated documents for regulatory compliance and accuracy.
• Review and approve SAP master data, including critical values and Bills of Materials.
• Ensure adherence to GMP standards and internal quality systems.
• Prepare, evaluate, and approve artwork for medicinal products.
• Draft and review operational SOPs and work instructions.
• Participate in QA projects and investigations as needed.
• Maintain and monitor quality metrics and update department boards.
• Collaborate with cross-functional teams such as Artwork, Master Data, Regulatory Affairs, and QA management.

Skills

GMP compliance

Quality Assurance

Documentation review

SAP data review

English fluency

Education

Bachelor's degree in Life Sciences or related field

Tools

SAP

Job description

Company

We are representing a leading organization in the life sciences industry, dedicated to ensuring the highest standards of quality and compliance across their manufacturing processes. Their focus is on delivering safe, effective products through rigorous quality management and continuous improvement.

Job Description

We are seeking a detail-oriented Quality Assurance Specialist with a GMP background to join their team on a temporary basis. This role involves reviewing artwork and master data to ensure compliance with quality standards. The position offers an excellent opportunity for those looking to develop their QA skills within a dynamic environment, with potential for longer-term employment.

Responsibilities

• Conduct quality reviews of artwork and associated documents for regulatory compliance and accuracy.
• Review and approve SAP master data, including critical values and Bill of Materials.
• Ensure adherence to GMP standards and internal quality systems.
• Prepare, evaluate, and approve artwork for medicinal products.
• Draft and review operational SOPs and work instructions.
• Participate in QA projects and investigations as needed.
• Maintain and monitor quality metrics, and update departmental performance boards.
• Establish and nurture effective working relationships with cross-functional teams such as Artwork, Master Data, Regulatory Affairs, and QA management.
• Support continuous improvement initiatives and problem-solving processes related to data integrity and compliance.

Requirements

• Bachelor's degree or higher in Life Sciences or a related field.
• Approximately 3 years of QA or manufacturing experience within the pharmaceutical or medical device industry.
• Strong understanding of GMP, GDP, and GCP regulations.
• Excellent attention to detail and accuracy.
• Fluent in English; Dutch language skills are a plus but not mandatory.
• Ability to learn new systems quickly, with training provided for SAP and artwork review processes.
• Willingness to commit to an initial six-month contract with no immediate guarantee of permanent employment.
• Willing to work onsite for 3-4 days during training and 2 days afterwards, with a preference for candidates residing within an hour's drive of Breda.

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