Key Skills

Job Description

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. Responsibilities 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. Qualifications MBO degree or equivalent qualification. Preferably 2 to 3 years of experience in the pharmaceutical, biotech, or related regulated industry. 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 practices. Detail-oriented and quality focused. Well organized and able to manage multiple documentation activities simultaneously. Results-driven and accountable. HAL Allergy, for those who seek pharmaceutical innovation HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. At Hall Allergy we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health.

Core Responsibilities

The Technical Writer will create and maintain critical manufacturing documentation, including Master Batch Records and SOPs, within a GMP-regulated environment. They will collaborate with cross-functional teams to translate complex production processes into compliant operational documents.

Requirements

Candidates should hold an MBO degree or equivalent and possess 2 to 3 years of experience in the pharmaceutical or biotech industry. Proficiency in GMP documentation practices and strong communication skills in both Dutch and English are required.

Benefits

• Growth opportunities
• Personal development
• Informal work environment