Job Description

• To review/approval/closure, rejection/drop (if required) of Quality system documents such as Deviation, change control, CAPA, OOS, OOT, Re-process & Re-work, market complaint, market returns & LIR.
• To ensure & handle the investigation for Out of Specification Results, OOT, Deviations, Product failures and Market Complaints are adequately performed and documented with appropriate Quality Risk Assessment activity, Corrective and Preventive Actions based on the results of the investigations are identified and implemented.
• To preparation review & Approval of Quality system trend.
• To verify In-process Quality Assurance during production activity and sampling at different stages of processing/packing as per requirement.
• To review & approval of API Analytical Method Transfer Protocol/Report and method validation documents.
• Preparation & review of Annual Product Quality Review.
• Preparation, Review & Approval of Hold Time Study Protocol/Reports, and other study protocols/reports

Work Experience
7-9 year
Education
Masters in Science or Pharmaceutical Chemistry
Post Graduation in Pharmacy
Competencies