Job Description

Description

  • Perform routine and stability sample analysis as per approved specifications and test methods
  • Operate and maintain analytical instruments (HPLC, GC, UV, Dissolution Apparatus, etc.)
  • Review and document analytical data in compliance with cGMP and data integrity principles
  • Investigate OOS/OOT results and support deviation and CAPA activities
  • Ensure compliance with FDA, cGMP, and GLP requirements
  • Prepare and review analytical reports, protocols, and SOPs
  • Participate in method transfer, verification, and validation activities
  • Support regulatory and internal audits
  • Strong knowledge of FDA regulations, cGMP, and data integrity
  • Analytical troubleshooting and problem-solving skills
  • Documentation and compliance expertise
  • Team collaboration and communication

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