Document Controller

EFOR; Frankfurt; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

EFOR in Frankfurt is seeking a meticulous Document Controller to support regulated operations. You will manage electronic documents, ensure compliance with ISO/GMP/GxP standards, and coordinate revision, approval, archival, and retrieval using Kneat and/or GDMS.

Fluency in German and English is required, with strong attention to detail and the ability to work both independently and within cross-functional teams. You will assist audits and train staff on document control processes.

Qualifikationen

• Proven experience as Document Controller or similar in regulated environments (pharma, biotech, engineering).
• Familiarity with ISO, GMP, GxP standards.
• Fluent in German and English (written and spoken).
• Experience with electronic documentation systems Kneat and/or GDMS.

Aufgaben

• Manage and control company documents per internal procedures and regulatory requirements.
• Ensure document classification, organization, and accessibility.
• Coordinate workflows: revision, approval, issuance, archival, retrieval.
• Maintain version control, audit trails, and change histories.
• Perform quality checks for accuracy, completeness, and compliance.
• Support audits and document reviews with internal/external teams.
• Liaise with Quality, Engineering, Operations; provide training on controls and systems.
• Use Kneat and/or GDMS for management, workflow, and reporting.
• Translate/review technical documents in German and English.

Kenntnisse

Attention to detail

Regulatory compliance

Communication skills

Team collaboration

Independent working

Bilingual (German/English)

Ausbildung

Quality / Document Control qualification

Tools

Kneat

GDMS

Jobbeschreibung

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.)
• Excellent attention to detail, organizational ability, and time management
• Strong communication and interpersonal skills
• Ability to work independently and as part of a team
• Experience supporting regulatory audits
• Familiarity with electronic batch records, validation protocols, and change management
• Technical background or relevant qualification in Quality or Document Control