Quality Systems - Documentation Specialist

Join Our Client as a Quality Systems - Documentation Specialist

Location: Hoofddorp, Netherlands
Contract Length: 12 months
Pay Rate: €50,000 - €56,000/annum
Work Structure: Monday - Friday, 40 H/W. 1 weekend shift every 6 weeks.
Benefits: Shift Allowance and Travel Allowance

About the Role:

We are seeking a meticulous and detail-oriented Quality Systems - Documentation Specialist I to join a pioneering cell therapy biotechnology company! The successful candidate will play a crucial role in verifying and managing controlled issued batch documents and labels, ensuring compliance with cGMP standards. This role requires a high level of accuracy and a proactive approach to identifying and addressing compliance gaps.

Responsibilities:

• Verify controlled issued batch documents and label packages, including final product labels, as per cGMP.
• Verify controlled issued logbooks.
• Ensure timely consumption of consumables/GMP materials or inform the responsible person.
• Ensure accuracy and completeness of QA issued documents.
• Identify and escalate compliance gaps in the controlled issuance process.
• Execute strategic initiatives to improve the controlled issuance process.
• Support and investigate deviations in the controlled issuance process and develop corrective action plans.
• Perform additional duties as assigned.

Education and Experience:

• HBO or WO level education.
• 2+ years' experience in document management within a regulated environment.
• Advanced level of English communication.
• Positive demeanour and strong technical knowledge of GMP.
• Ability to clearly present and explain document issuance operations and guidelines to internal audiences.
• Ability to cross-train colleagues and customers.
• Effective communication with stakeholders, senior colleagues, and peers.
• Ability to think outside the process and consider the impact of decisions on other areas.
• Ability to prioritise and meet deadlines.
• Strong attention to detail and accuracy in routine tasks.
• Effective communication skills with peers and stakeholders.

Why Join Us?

This is your chance to be part of a groundbreaking team in the Biotechnology sector, contributing to the development of life-changing therapies. If you are passionate about innovative science and have the expertise we're looking for, we'd love to hear from you.

Apply now to take the next step in your career with a company that values innovation, dedication, and professional growth.

Please note: You must be able to work in the EU without restriction or sponsorship to be eligible for this role. If you are interested in finding out more about this role or others, please contact Jada Kirlew at jkirlew@i-pharmconsulting.com or call: +44 (0)20 7551 0727 (UK) / +31 208 089 982 (NL)