GMP Documentation & Quality Operations 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

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