Documentation Specialist

SIRE LIFE SCIENCES; Hoofddorp; On-site; EUR 40,000 - 65,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking a Quality Operations Documentation Specialist I to oversee accuracy and control of GMP documentation used in manufacturing. You will issue, verify, and manage controlled documents, labels, and logbooks while supporting continuous improvement and regulatory compliance.

Key responsibilities include verifying batch documents and label packages, maintaining QA documents, addressing compliance gaps, and coordinating with internal stakeholders to ensure timely, accurate

Qualifications

• Advanced English communication skills.
• Strong knowledge of GMP regulations and documentation practices.

Responsibilities

• Verify controlled issued batch documents and label packages per cGMP requirements.
• Verify controlled issued logbooks for accuracy and completeness.
• Ensure timely consumption of GMP materials or communicate inventory requirements.
• Maintain accuracy and completeness of QA issued documents.
• Identify and upscale compliance gaps within the controlled issuance process.
• Support process improvement initiatives related to document control and issuance.
• Investigate and support deviations related to controlled issuance activities.
• Develop and implement corrective action plans when required.
• Communicate document issuance requirements to internal stakeholders.
• Cross train colleagues and customers on document issuance processes.
• Collaborate with peers, stakeholders and senior colleagues.
• Consider operational impacts when making documentation decisions.

Skills

English communication

GMP knowledge

Attention to detail

Organizational skills

Deadline driven

Problem solving

Stakeholder management

Education

HBO/WO level education

Job description

The Company

A leading organization in the life sciences and pharmaceutical manufacturing sector focused on producing high quality products in a highly regulated environment. The company operates under strict quality and compliance standards, ensuring patient safety and regulatory excellence through robust GMP practices.

Role description

As a Quality Operations Documentation Specialist I, you will play a key role in ensuring the accuracy, control, and compliance of GMP documentation used throughout manufacturing operations. The position focuses on the issuance, verification, and management of controlled documents, labels, and logbooks while supporting continuous improvement initiatives and maintaining regulatory compliance.

Responsibilities

• Verify controlled issued batch documents and label packages, including final product labels, in accordance with cGMP requirements
• Verify controlled issued logbooks for accuracy and completeness
• Ensure timely consumption of GMP materials and consumables or communicate inventory requirements to responsible personnel
• Maintain accuracy and completeness of QA issued documents
• Identify and upscale compliance gaps within the controlled issuance process
• Support process improvement initiatives related to document control and issuance
• Investigate and support deviations related to controlled issuance activities
• Develop and implement corrective action plans when required
• Communicate document issuance requirements and guidelines to internal stakeholders
• Cross train colleagues and customers on document issuance processes
• Collaborate effectively with peers, stakeholders, and senior colleagues
• Consider operational impacts when making decisions related to documentation processes
• Perform additional duties as assigned

Requirements

• HBO or WO level education
• Minimum 2 years of document management experience within a regulated environment
• Advanced English communication skills
• Strong knowledge of GMP regulations and documentation practices
• Excellent attention to detail and commitment to accuracy
• Strong organizational and prioritization skills
• Ability to meet deadlines in a fast paced environment
• Strong problem solving and investigation skills
• Effective stakeholder management and communication skills