Establishing Regulatory Compliance
2 days ago
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Quality Document Management SpecialistWe are partnering with a leading pharmaceutical company to create a fantastic opportunity for a Quality Document Management Specialist.
Job Overview
You will ensure all controlled documents meet regulatory standards in terms of formatting, layout, numbering, and metadata. The role involves working across multiple systems, collaborating closely with the Learning & Development team to ensure training materials and documents meet technical standards.
Key Responsibilities- Review and approve controlled documents across EDMS (Veeva Vault or similar), ValGenesis, and RMS for formatting, numbering, and metadata compliance.
- Ensure adherence to standards for page layout, fonts, headers/footers, numbering, and other formatting conventions.
- Support change control processes by verifying document attributes during revisions.
- Validate document metadata (author, version, effective date, approvals) for accuracy and completeness.
- Perform print issuance, indexing, and archiving of documents in accordance with GMP standards.
- Collaborate with authors, reviewers, approvers, and the Learning & Development team to ensure consistency across training and operational documents.
- Participate in internal and external audits, providing evidence of document compliance and technical integrity.
- Identify and implement opportunities to improve document management processes and system integration.
- Bachelor's degree in a scientific or technical discipline.
- 2+ years' experience in quality assurance or a related function in a regulated environment.
- Experience with EDMS (Veeva Vault or similar) and familiarity with ValGenesis and RMS.
- Strong knowledge of regulations and best practices.
- Detail-oriented, organized, and able to manage multiple priorities under deadlines.
- This is an exciting opportunity to join a new manufacturing plant being established.
- As a Quality Document Management Specialist, you will play a critical role in setting up and maintaining document standards and compliance processes from the ground up.
- Seniority level: Not Applicable
- Employment type: Contract
- Job function: Quality Assurance and Writing/Editing
- Industries: Pharmaceutical Manufacturing and Biotechnology Research
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