Document Review Analyst

Description

Position Summary: We are seeking technicians or professionals in chemistry/pharmaceutical sciences to join us as a Document Review Analyst, ensuring compliance with technical specifications and pharmacopoeial standards. Key Responsibilities: 1. Review and verify internal and external analytical packages 2. Identify and report documentation deviations or inconsistencies 3. Update and maintain the list of active pharmaceutical ingredient (API) potencies Fabrifarma S.A.S is seeking technicians or professionals in chemistry or pharmaceutical chemistry to perform duties as a Document Review Analyst. Key responsibilities include: Reviewing and verifying internal and external analytical packages, ensuring compliance with applicable technical specifications and pharmacopoeial standards for materials used in the manufacture of Finished Products. Comparing analytical results in detail against requirements specified in methods, monographs, and current regulations. Promptly identifying, documenting, and reporting to the Head of Quality Control any deviation, inconsistency, or non-compliance detected during document review. Consolidating internal and external analytical results for materials to ensure their proper inclusion and traceability in the Batch Record for each product. Promptly notifying Quality Assurance Inspectors of the status change of materials from quarantine to release for use, ensuring correct documentary release and process traceability. Updating and maintaining the list of active pharmaceutical ingredient (API) potencies, guaranteeing the availability and reliability of information required by the Production department for manufacturing processes.-Requirements- Minimum education: University degree / Technical program 1 year of experience Keywords: analyst