Document Controller/Project Planner (CQV/CSV)
Summary
Manages documentation workflows and project plans for pharmaceutical systems using Veeva GVLMS v2, ensuring compliance with cGMP and data integrity standards.
You will be responsible for:
- System & Documentation Lifecycle Management: Managing and maintaining the documentation workflow for CQV and CSV workstreams, supporting direct-impact systems across Drug Substance, Drug Product, QC and Utilities.
- Veeva GVLMS v2 Management: Coordinating entity creation, document routing, pre- and post-approval tracking, and revision maintenance in Veeva GVLMS v2 against approved project system lists.
- Digitization & True Copy Verification: Managing paper-to-digital conversions, scanning execution evidence, and performing True Copy Verification within Veeva GVLMS v2.
- Project Planning & Progress Tracking: Developing and updating detailed documentation delivery schedules, tracking KPIs, and monitoring document approval workflows to prevent project bottlenecks.
- Compliance & Audit Readiness: Ensuring all documentation adheres to global pharma standards, cGMP, and Data Integrity guidelines, maintaining an organized and continuously audit-ready repository.
About you:
- Experience: A minimum of 5 years of experience in document control, project planning, or PMO support within the pharmaceutical industry, specifically handling C&Q, CSV, or engineering documentation.
- Technical System Expertise: Hands-on experience with Electronic Document Management Systems (EDMS) and paperless validation software (experience with Veeva GVLMS / Paperless Validation platforms is a major advantage).
- Planning & Tools Proficiency: Proficiency in MS Project, Excel, or scheduling tools, with strong organizational skills to track hundreds of technical deliverables across multiple building phases.
- Regulatory Understanding: Solid understanding of cGMP, Data Integrity (ALCOA+), and document control standards relevant to pharma project execution.