Job Description
Must-Haves
- 2–5 years of experience in documentation management within the pharmaceutical or nutraceutical industry
- Strong knowledge of GMP, GDP, FDA regulations, and ISO standards
- Proficiency with documentation systems and software (e.g., Microsoft Office, document control platforms)
- Bachelor’s degree in pharmaceutical sciences, engineering, or life sciences
Plusses
- Familiarity with Softgel manufacturing processes
- Experience with electronic documentation systems
- Exposure to regulatory frameworks beyond FDA (e.g., EMA, global standards)
- Prior involvement in audits or regulatory inspections
- Experience supporting product development or technology transfer projects
Role Overview
This role is responsible for creating, revising, and managing technical documentation within a pharmaceutical or nutraceutical manufacturing setting, with a specific emphasis on Softgel production. The position supports cross-functional teams including production, quality assurance, customer service, purchasing, and R&D, ensuring compliance with regulatory standards and operational excellence.
Day-to-Day Responsibilities
- Create, review, revise, and maintain SOPs, specifications, batch records, master formulas, protocols, and reports
- Implement document control systems aligned with Good Documentation Practices (GDP)
- Maintain accurate records of manufacturing processes in compliance with FDA, GMP, and other standards
- Prepare technical documents for product development, validation, and technology transfer
- Collaborate with production and quality teams to resolve documentation discrepancies
- Document deviations, investigations, and CAPAs accurately
- Provide documentation for internal and external audits
- Ensure all documents meet regulatory compliance standards (FDA, EMA, etc.)
- Update documents in response to regulatory changes or process improvements
- Act as a liaison between manufacturing, R&D, quality, and regulatory teams
- Train staff on documentation standards and GDP
- Participate in change control processes and ensure timely updates
- Identify and implement improvements to documentation processes
- Manage electronic documentation systems when applicable
- Monitor industry trends and ensure ongoing compliance
Job Tags
Work at office,