Documentation Manager – Food, Pharma & Environmental Labs

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Role Summary

The Documentation Manager will lead the controlled-documentation function for all Food, Pharma and Environmental laboratories of EFRAC. The person must have deep understanding of 17025 documentation requirements and strong exposure to documentation practices followed in USFDA-approved pharmaceutical facilities. This role ensures that every SOP, test method, instrument logbook, worksheet, checklist, form, manual and regulatory document is accurate, compliant, and audit-ready at all times.

Key Responsibilities

1. Documentation Control & Compliance

• Manage the complete controlled-document system across all divisions.
• Ensure all SOPs, methods, forms, logbooks, equipment documents and checklists meet ISO/IEC 17025 and ISO 17034 requirements.
• Maintain master document lists, version control, distribution records and archival systems.
• Drive periodic document reviews and ensure timely revisions.
• Ensure only the latest approved versions are accessible on the floor.

2. Audit Preparedness & Regulatory Management

• Prepare and maintain documentation for NABL, FSSAI, EIC, APEDA, CPCB, WBPCB, pharma audits and client audits.
• Support documentation for accreditation submissions, renewals, technical updates and CAPA responses.
• Apply documentation practices aligned with USFDA expectations, especially data integrity, ALCOA+ principles and GDP.
• Ensure manuals, technical documents and quality records are consistently updated.

3. Operational Documentation Oversight

• Ensure complete documentation coverage for every test and activity: worksheets, calculations, test records, checklists and templates.
• Oversee instrument-related documentation including logbooks, calibration/maintenance records, daily checks and performance logs.
• Ensure proper documentation control for sample workflow and analytical processes.
• Work closely with department heads to ensure operational accuracy and alignment.

4. Governance, Standardisation & Improvement

• Conduct internal documentation audits, monthly gap checks and compliance reviews.
• Standardise formats across all labs and reduce variation or duplication.
• Strengthen GDP practices and improve document readiness for audits.
• Support digitisation and structured documentation workflows (including LIMS).

5. Training & Team Coordination

• Train lab and QA teams on documentation requirements, revisions and audit-readiness.
• Guide teams in drafting, reviewing and maintaining SOPs and controlled records.
• Act as the go-to person for document clarifications and regulatory expectations.

Qualifications

• M.Sc in Chemistry / Microbiology / Biotechnology or related field.
• 10–15 years of documented experience handling controlled documents in accredited labs.
• Strong background in ISO/IEC 17025 documentation systems.
• Experience in a USFDA-approved pharmaceutical facility is highly preferred.
• Clear understanding of GDP, ALCOA+ principles and audit expectations.

Key Skills & Attributes

• High accuracy and strong documentation discipline.
• Deep understanding of regulated lab operations.
• Ability to manage large volumes of documents systematically.
• Strong communication and coordination skills.
• Ability to work under audit pressure and tight timelines.