Quality Assurance(AQA)

Key Responsibilities

• Responsible for review of stability protocol & report.
• Responsible for Preparation of Annual Product Quality Review.
• Responsible for review of Master Packing Card & Master Formula Card.
• Responsible for preparation and review of Process validation Protocols and reports.
• Responsible for review of Batch Manufacturing and Batch Packing records
• Responsible for preparation of batch release certificate and ensuring batch release process performed as per the SOP.
• Responsible for issuance of Formats, Logbooks, Register, protocol, reports, BMRs and BPRs as per respective procedure.
• Responsible for review of QC documents such as Specifications and Standard Testing Procedure (RM, bulk, finished product, RST).
• Responsible for review of COAs (Raw Material, Packing Material & Finished Product).
  

Key Skills & Competencies

• Sound knowledge of cGMP, GLP, and data integrity principles.
• Experience in review of analytical data generated through HPLC, GC, UV, IR, Dissolution, etc.
• Good understanding of analytical method validation and transfer.
• Proficient in documentation and good communication skills.
• Familiar with regulatory expectations (USFDA, MHRA, WHO, etc.).