Jobid: 635290174898047824 (0.0503)
Technical Writer
At HAL Allergy Group, we are committed to improving lives through high-quality allergy diagnostics and immunotherapy products. To support our growing manufacturing organization, we are looking for a detail-oriented and proactive Technical Writer who will play a key role in creating and maintaining GMP production documentation.
As a Technical Writer, you will be responsible for the creation, maintenance, and continuous improvement of GMP documentation that supports our manufacturing operations. You will work closely with Production, Quality, and Technology Transfer teams to ensure documentation remains accurate, compliant, user-friendly, and aligned with current manufacturing practices.
Your work will directly contribute to the reliable and compliant production of pharmaceutical products in a dynamic GMP environment.
Your tasks
Create, revise and maintain Master Batch Records, SOPs, Work instructions and other GMP documentation required to support manufacturing operations.
Update effective/active Batch Records, e.g. as part of Change Controls or CAPAs.
Support the standardization and harmonization of GMP documentation across manufacturing operations by implementing and maintaining document templates for the operations in GMP. Ensure accurate set-up, maintenance and when necessary, re-design of templates and other documents.
Partner closely with Production, Quality, and subject matter experts to ensure GMP documentation accurately reflects current manufacturing processes and regulatory requirements.
Participate in lessons learned sessions, operational reviews, and continuous improvement initiatives, translating identified improvements into updated batch records, SOPs, work instructions, and other controlled documents.
Plan and monitor the document delivery process from draft to approval for batch records and other documents within the Production department.
Align with the document users, reviewers and authorizers of the documents to ensure document review, authorization, and archival processes are completed according to applicable procedures.
Train production operators and other stakeholders on the implementation of new or revised GMP documentation when required.
Support the introduction of new products and processes by developing and implementing the required GMP manufacturing documentation.
You have
MBO level education.
Preferably 2-3 years of experience in a pharmaceutical, biotechnology, or regulated manufacturing environment.
Strong proficiency in Microsoft Office, particularly Word.
Excellent command of Dutch and English, both written and spoken.
Understanding of manufacturing processes such as formulation, fill-finish, and preferably lyophilization.
Knowledge of GMP principles and documentation practices.
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