Sr. Executive - Equipment Qualification - OSD Dosage form

Role & responsibilities

• Protocol Development & Authoring: Draft, review, and finalize User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and existing equipment.
  
• Qualification Execution: Lead on-site execution of IQ/OQ/PQ protocols, coordinate thermal mapping, filter integrity testing, and instrument calibrations, ensuring zero compliance deviations.
  
• Data Verification & Report Generation: Analyze test results, perform data integrity checks, and compile comprehensive final qualification reports (FQRs) to document system fitness for routine operational use.
  
• Cross-Functional Coordination: Collaborate closely with Quality Assurance (QA), Engineering, Maintenance, and Production teams to align qualification schedules and minimize facility downtime.
  
• Deviation & CAPA Management: Investigate non-conformances or out-of-specification (OOS) events during execution, conduct Root Cause Analysis (RCA), and implement Corrective and Preventive Actions (CAPA).
  
• Re-qualification & Change Control: Manage periodic equipment re-qualification schedules and evaluate change controls to determine the impact of physical or software modifications on qualified systems.
  
• Audit Readiness & Defense: Maintain qualification documentation in an audit-ready state and act as a subject matter expert (SME) to defend validation packages during internal and regulatory inspections (e.g., US FDA, EMA, WHO).
  
• Vendor & Third-Party Oversight: Supervise equipment vendors during Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), ensuring vendor-provided validation packages align with site SOPs.
  
• SOP Drafting & Maintenance: Draft, revise, and update Standard Operating Procedures (SOPs) for equipment operation, preventative maintenance, and routine calibration.