GMP Documentation Specialist

Project overview

-Creation, revision, and maintenance of GMP-relevant documentation for new development products

-Support with GMP-compliant documentation in the context of product developments and product launches

-Working with new and existing document templates

-Gathering and preparing information from various specialist areas to create the required documents

-Support in the change control process, including training and documentation of changes

-Preparation and structuring of data and documentation in Excel for later transfer into the respective systems

-Tracking and documentation of technical issues and production-relevant topics (e.g., filtration processes)

-Coordination with various stakeholders and participation in regular project meetings

-Ensuring GMP compliance of all created documentation

Requirements

-Studies in Pharmacy, Chemistry, Biology, Biotechnology, or a comparable natural science

-PhD desirable, ideally in the field of pharmaceutical technology

-Experience in the pharmaceutical industry required

-Ideally, knowledge from production, tech transfer, pharmaceutical development, or manufacturing science

-Experience with GMP documentation and change control processes

-Proficient in Excel and document management systems

-Structured, independent, and meticulous way of working

-Fluent German and English skills!

Project details

6 months

Utilization: 100 %

Assignment: 100 % Remote

01.12 at the latest 01.01

• Start: 2026-12
• Duration: 5 Monate
• Remote: remote
• Location: Frankfurt, Deutschland, DE
• Languages: German