Company
A global pharmaceutical organization focused on animal health, vaccines, and high-quality pharmaceutical production. The company operates in a highly regulated GMP environment and is committed to quality, innovation, and continuous improvement across its production and quality operations.
Role Description
As a Quality Auditor, you will act as the link between Quality and Production, ensuring that manufacturing processes comply with GMP regulations and internal quality standards. You will support validation, qualification, investigations, and documentation review while working closely with production, quality control, and improvement teams to maintain and improve quality processes.
Responsibilities
- Advise, support, and approve equipment installation, qualification, and validation activities.
- Support root cause investigations and approve investigation documentation related to deviations and abnormalities.
- Review and approve production documentation, protocols, and GMP documentation.
- Ensure production processes comply with GMP requirements, internal quality standards, and regulatory requirements.
- Work closely with production, quality control, and improvement teams to maintain and improve quality processes.
- Support continuous improvement initiatives and quality process optimization.
- Act as the quality representative within the production environment.
- Ensure proper documentation, compliance, and quality oversight across production operations.
Requirements
- Bachelor’s or Master’s degree in a relevant field.
- Strong knowledge of GMP and regulatory requirements (Eudralex knowledge is a plus).
- Experience with validation and qualification within a GMP-regulated environment.
- Ability to independently manage projects and improvement initiatives.
- Strong communication skills in English & Dutch.
- Proactive, solution-oriented, and quality-focused mindset.
- Strong sense of ownership and ability to work in cross-functional teams.
- Experience in pharmaceutical, biotechnology, or regulated manufacturing environments is preferred.
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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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
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