Document Controller

Overview:

We are seeking a meticulous and proactive Document Controller to join our team. The ideal candidate will be fluent in German and have prior experience with electronic documentation systems such as Kneat and GDMS. This role is critical in ensuring compliant document management in support of regulated operations.

Key Responsibilities:

• Manage and control company documents in accordance with internal procedures and regulatory requirements
• Ensure proper document classification, organization, and accessibility
• Coordinate documentation workflows including revision, approval, issuance, archival, and retrieval
• Maintain document version control, audit trails, and change histories
• Perform quality checks on documents for accuracy, completeness, and compliance
• Support document reviews and alignments during internal and external audits
• Liaise with internal stakeholders (Quality, Engineering, Operations) and external partners as needed
• Provide guidance and training on document control processes and the use of documentation systems
• Utilize Kneat and/or GDMS platforms for document management, workflow administration, and reporting
• Translate or review technical documents in German and English, ensuring linguistic and regulatory accuracy
• Prepare regular reports on documentation status and metrics

Requirements:

• Fluent in German and English (written and spoken)
• Previous experience in a Document Controller or similar role within a regulated environment (pharma, biotech, engineering, etc.)
• Experience with electronic documentation systems; Kneat and GDMS preferred
• Good understanding of document control standards (ISO, GMP, GxP, etc.)
• Strong IT skills (MS Office, SharePoint, etc.)
• Excellent attention to detail, organizational ability, and time management
• Strong communication and interpersonal skills
• Ability to work independently and as part of a team

Desirable:

• Experience supporting regulatory audits
• Familiarity with electronic batch records, validation protocols, and change management
• Technical background or relevant qualification in Quality or Document Control