Quality Assurance(AQA)

As a Quality Control Officer, your primary role will involve reviewing stability protocols & reports, preparing Annual Product Quality Reviews, reviewing Master Packing Card & Master Formula Card, preparing and reviewing Process Validation Protocols and reports, reviewing Batch Manufacturing and Batch Packing records, preparing batch release certificates, and ensuring batch release processes are in line with SOPs. You will also be responsible for issuing Formats, Logbooks, Registers, protocols, reports, BMRs, and BPRs as per the respective procedures. Additionally, you will review QC documents such as Specifications and Standard Testing Procedures for raw materials, bulk products, finished products, and RST, as well as Certificates of Analysis for Raw Material, Packing Material & Finished Product. Key Responsibilities: - Review stability protocols & reports - Prepare Annual Product Quality Review - Review Master Packing Card & Master Formula Card - Prepare and review Process validation Protocols and reports - Review Batch Manufacturing and Batch Packing records - Prepare batch release certificate and ensure batch release process is as per SOP - Issue Formats, Logbooks, Registers, protocols, reports, BMRs, and BPRs as per respective procedure - Review QC documents such as Specifications and Standard Testing Procedure (RM, bulk, finished product, RST) - Review Certificates of Analysis (Raw Material, Packing Material & Finished Product) Qualifications Required: - Sound knowledge of cGMP, GLP, and data integrity principles - Experience in reviewing analytical data generated through HPLC, GC, UV, IR, Dissolution, etc. - Good understanding of analytical method validation and transfer - Proficient in documentation and possess good communication skills - Familiarity with regulatory expectations from USFDA, MHRA, WHO, etc.,