The Company
A global organization specialized in pharmaceutical and biological products for animal health. The company operates internationally, focusing on developing, producing, and distributing high-quality vaccines and medicines for worldwide markets.
About the Role
The Senior Quality Assurance Officer ensures GMP compliance across production processes, documentation, validation, qualification, deviations, and change control. The role supports continuous improvement, performs reviews and approvals of production and analytical records, and conducts internal audits to maintain cGMP and regulatory compliance. It serves as a key link between Quality and manufacturing teams.
- Conduct routine audits of data, systems, equipment, procedures, and facilities to ensure compliance with SOPs, GMPs, and regulatory standards.
- Review and approve production and analytical documentation for API, safety assessment, and clinical supplies prior to release.
- Communicate audit findings, align with stakeholders, and ensure timely resolution of comments.
- Perform and support deviation investigations, root cause analyses, and change control processes.
- Advise, support, and approve equipment installation, qualification, and validation activities.
- Ensure daily operations comply with applicable guidelines and policies.
- Act as first point of contact for GMP-related questions in production areas.
- Issue audit/inspection reports, summarize deficiencies, and follow up on corrective actions.
- Bachelor’s or Master’s degree in a scientific or technical discipline.
- Experience in the pharmaceutical/chemical industry or a drug-regulatory authority.
- Strong working knowledge of cGMP regulations (including EudraLex).
- Proven experience in deviation management, change management, validation, and qualification.
- Ability to interpret regulations and apply them in both routine and exceptional situations.
- Strong communication skills in English and Dutch.
- Proactive, supportive mindset with strong ownership and problem-solving skills.
- Ability to manage projects and improvement initiatives independently.
Opportunities for professional growth toward more senior quality roles.
#J-18808-Ljbffr