GMP Documentation Specialist - Quality & Compliance

NES Fircroft; Hoofddorp; On-site; EUR 42,000 - 66,000; Full time

Job summary

NES Fircroft is seeking a Documentation Specialist to join a highly regulated pharmaceutical/biotech Quality team. The role focuses on accuracy, compliance, and timely issuance of GMP documentation supporting manufacturing and quality operations.

You will work with multiple departments to maintain high standards and contribute to continuous process improvements, ensuring proper controlled documentation, batch records, and logbooks are maintained in line with cGMP requirements.

Qualifications

• Minimum 2 years of experience in document management within a regulated environment.
• Strong knowledge of GMP/cGMP requirements.
• Experience with controlled documents, batch records, logbooks, SOPs, or quality documentation.

Responsibilities

• Review and verify batch records, label packages, and final product labels in accordance with cGMP requirements.
• Verify controlled logbooks and GMP documentation.
• Ensure the accuracy, completeness, and compliance of QA-issued documents.
• Support the timely issuance and management of controlled documentation.
• Identify compliance gaps and escalation issues where appropriate.
• Participate in investigations related to document issuance processes and support CAPAs.
• Contribute to continuous improvement initiatives within Quality Operations.
• Collaborate with internal stakeholders across various departments.
• Support training and knowledge sharing activities within the team.
• Maintain a high level of accuracy while meeting deadlines in a fast-paced environment.

Skills

GMP documentation

Quality documentation

Controlled documents

Attention to detail

English communication

Education

HBO/WO degree

Job description

NES Fircroft is seeking a Documentation Specialist to join a highly regulated pharmaceutical/biotech Quality team. The role focuses on accuracy, compliance, and timely issuance of GMP documentation supporting manufacturing and quality operations.

You will work with multiple departments to maintain high standards and contribute to continuous process improvements, ensuring proper controlled documentation, batch records, and logbooks are maintained in line with cGMP requirements.