Documentation Specialist

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

Location: Hoofddorp

Full-time

Rotating weekend schedule (1 weekend every 6 weeks)

About the Role

Are you detail-oriented, quality-driven, and experienced in GMP documentation? We are looking for a Documentation Specialist to join a dynamic Quality team within a highly regulated pharmaceutical/biotech environment.

In this role, you will play a key part in ensuring the accuracy, compliance, and timely issuance of GMP documentation that supports manufacturing and quality operations. You will work closely with multiple departments to maintain high quality standards and contribute to continuous process improvements.

Key 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 corrective and preventive actions (CAPAs).
• Contribute to continuous improvement initiatives within Quality Operations.
• Collaborate effectively 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.

What We're Looking For

• HBO or WO degree.
• Minimum 2 years of experience in document management within a regulated environment.
• Strong knowledge of GMP/cGMP requirements.
• Excellent attention to detail and commitment to quality.
• Experience working with controlled documents, batch records, logbooks, SOPs, or quality documentation.
• Strong communication skills in English, both written and verbal.
• A proactive, positive, and collaborative mindset.
• Ability to prioritize work effectively and manage multiple tasks simultaneously.

Working Schedule

This position follows a rotating schedule, including one working weekend every six weeks. Employees receive compensatory days off during these rotations, ensuring a balanced work schedule.

Please note, suitable candidates must have a right to work in NL without the need for sponsorship. Any candidates who require sponsorship cannot be considered.