GMP Quality Specialist, Boxmeer, Noord-Brabant

The Company
A well?established organization operating within the pharmaceutical and chemical manufacturing sector, recognized for maintaining strong regulatory standards. The company focuses on high?quality production processes, regulatory compliance, and continuous operational improvement.

Role Description
The GMP Quality Specialist ensures full compliance of production processes, facilities, documentation, and equipment with cGMP, SOPs, and international regulatory guidelines. This role plays a key part in overseeing process transfers, supporting validation activities, conducting internal audits, and ensuring that investigations and quality records meet regulatory and company expectations.

Responsibilities
- Conduct routine audits of procedures, processes, systems, equipment, and facilities to ensure compliance with SOPs, GMPs, and regulatory requirements.
- Review and approve production and analytical documentation for release of API, Safety Assessment, or clinical supply lots.
- Supervise and support the transfer of production processes to new facilities, including validation reviews and approvals.
- Advise, support, and approve equipment installation, qualification, and validation activities.
- Communicate audit findings, work with teams to resolve issues, and issue audit reports summarizing deficiencies.
- Support and approve root cause investigations and nonconformity documentation.
- Notify appropriate management of inspection results.
- Collaborate with teams to drive remediation and continuous improvement.

Requirements
- Experience in the pharmaceutical or chemical industry or with a government drug-regulatory agency.
- Strong knowledge of cGMP regulations and compliance requirements.
- 5–8 years of experience (manager specifically seeks candidates with sales experience, though the functional need is Quality/Validation).
- Proficiency in reviewing and approving production documentation, validation protocols, and investigations.
- Experience with equipment qualification and validation.
- Effective written and verbal communication skills.
- Strong interpersonal skills and ability to work cross?functionally.
- Experience performing audits or inspections in line with regulatory standards.

Other Information
Works with moderate direction and requires strong technical competence.
May involve on-site presence during process transfers and equipment validations.

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