Job Description

Must-Haves

• 25 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)
• Bachelors 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

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