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HAL Allergy Technical Writer @ Employer

NL363, NLOnsiteContract
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About this role

Technical Writer General information Technical Writer Are you passionate about creating clear, accurate, and compliant documentation in a GMP-regulated environment? We are looking for a Technical Writer to join our Technology Transfer team. In this role, you will play a key part in the successful introduction of new pharmaceutical products and processes by developing and maintaining critical manufacturing documentation. You will work closely with cross-functional teams to translate complex production processes into high-quality batch records, procedures, and operational documents that support safe and compliant manufacturing operations. Your tasks - Create and maintain Master Batch Records (MBRs) and Batch Records for new products and manufacturing processes. - Update existing manufacturing documentation as part of change controls, CAPAs, and continuous improvement initiatives. - Develop, manage, and improve document templates used within GMP manufacturing operations. - Collaborate with subject matter experts and project teams to gather technical information and translate it into clear, compliant documentation. - Coordinate document reviews, approvals, and implementation activities. - Train production operators on new or revised batch records. - Support Technology Transfer projects by documenting new processes and ensuring sustainable knowledge transfer. - Create and maintain Standard Operating Procedures (SOPs) within the Technology Transfer department. You have - MBO degree or equivalent qualification. - Preferably 2 to 3 years of experience in the pharmaceutical, biotech, or related regulated industry. - Experience with Microsoft Office, particularly Microsoft Word. - Strong written and verbal communication skills in both Dutch and English. - Understanding of pharmaceutical manufacturing processes such as formulation, fill-finish, and preferably lyophilization. - Knowledge of GMP requirements and documentation practice...

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