GMP Technical Writer – Pharma Tech Transfer

HAL Allergy Group; Leiden; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

30 leave days

Pension contribution

Health insurance

Job summary

HAL Allergy Group in Leiden is seeking a Technical Writer to join the Technology Transfer team. You will translate complex manufacturing processes into high-quality batch records, SOPs, and operational documents that support safe, compliant production.

You will collaborate with SMEs, support change controls, CAPAs, and continuous improvement, and train operators on new batch records, ensuring effective knowledge transfer across projects in a GMP setting.

Qualifications

• 2–3 years of experience in pharmaceutical/biotech regulated industry.
• Experience with Microsoft Word and MS Office.
• Strong written and spoken English and Dutch communication.
• Understanding of pharmaceutical manufacturing processes (formulation, fill-finish, lyophilization).
• Knowledge of GMP requirements and documentation practices.

Responsibilities

• Create and maintain Master Batch Records (MBRs) and Batch Records for new products and processes.
• Update manufacturing documentation as part of change controls, CAPAs, and continuous improvement.
• Develop, manage, and improve document templates for GMP operations.
• Collaborate with subject matter experts to translate technical information into compliant docs.
• 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 knowledge transfer.
• Create and maintain SOPs within the Technology Transfer department.

Skills

Documentation

Communication

GMP knowledge

Pharma processes

Tools

Microsoft Word

Job description

HAL Allergy Group in Leiden is seeking a Technical Writer to join the Technology Transfer team. You will translate complex manufacturing processes into high-quality batch records, SOPs, and operational documents that support safe, compliant production.

You will collaborate with SMEs, support change controls, CAPAs, and continuous improvement, and train operators on new batch records, ensuring effective knowledge transfer across projects in a GMP setting.