Nederland

Quality Compliance Specialist (GMP), Boxmeer

Quality Compliance Specialist (GMP), Boxmeer
Advertentietekst
The Company Our client is a leading global pharmaceutical and life sciences organization with a strong presence in the Netherlands, focused on developing and manufacturing innovative medicines and vaccines. The company operates advanced GMP-compliant production and quality facilities, supporting both biological and chemical processes.

Role Description We are seeking a detail-oriented Quality Compliance Specialist (GMP) to join our client’s team. In this role, the successful candidate will conduct routine audits of data, procedures, equipment, and systems to ensure compliance with SOPs, GMPs, and international regulations. This position involves reviewing documentation related to the release of active pharmaceutical ingredients (API), safety assessments, and clinical supplies, ensuring adherence to all regulatory standards.

Responsibilities

Perform routine audits of processes, data, equipment, and systems, including computer systems and facilities, to confirm compliance with established standards.

Review and approve production and analytical documentation for the release of bulk and packaged products, ensuring regulatory compliance.

Communicate audit findings, review comments, and work with relevant areas to address and resolve issues.

Conduct inspections or audits of assigned areas or systems, under supervision or as part of a team, to assess compliance with regulatory and company standards.

Prepare audit reports that detail deficiencies and collaborate with teams to implement corrective actions.

Notify management of audit results and follow up on remedial measures to ensure ongoing compliance.

Requirements

Experience with quality audits within pharmaceutical or regulated industries preferred.

Knowledge of GMP, SOPs, and international regulatory standards.

Strong attention to detail and communication skills.

Ability to work both independently and as part of a team.

Proficiency in Dutch and English.

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Quality Compliance Specialist (GMP) is geplaatst in de Boxmeer financieel, fiscaal rubriek op Locanto.

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