QA Sterile - Assistant Manager

USV PRIVATE LIMITED; Daman; On-site; INR 600,000 - 900,000; Full time

Job summary

USV PRIVATE LIMITED is seeking a QA professional to manage the documentation lifecycle (SOPs, Logbooks, BMRs, BPRs) and maintain the documentation cell. The role includes IPQA line clearances, in-process checks, and AQL inspections across manufacturing, packing, and aseptic areas.

You will oversee aseptic processing, media fills, sampling, and dispensing verification, while ensuring cGMP compliance on the shop floor.

Responsibilities

• Documentation & Document Control: Manage the complete lifecycle (preparation, issuance, retrieval, and destruction) of all QA documents, including SOPs, Logbooks, BMRs, and BPRs, while maintaining the documentation cell.
• In-Process Quality Assurance (IPQA): Conduct line clearances, perform in-process checks, and execute Acceptable Quality Level (AQL) inspections across general manufacturing, packing, and aseptic areas .
• Aseptic Area Oversight & Media Fills: Provide strict QA oversight during aseptic processing, manage aseptic process simulations (media fills), and prepare related protocols, trend reviews, and personnel tracking matrices .
• Sampling & Dispensing Verification: Oversee sample collection for commercial, submission, and validation batches, and rigorously verify the dispensing of raw and packaging materials .
• Shop-Floor Compliance & Environmental Monitoring: Ensure strict cGMP compliance through frequent shop-floor rounds, monitor environmental controls/cleanliness, and verify routine equipment printouts (CIP/SIP, Autoclaves, incubators) .
• Validation & Qualification Execution: Actively participate in the preparation and execution of Process Performance Qualifications, Cleaning Validation protocols, Hold Time studies, and Master Formula Records (MFR) .
• Product Reviews & Audit Trails: Prepare Annual Product Quality Reviews (APQR), inspect finished product consignments, manage control samples, and review equipment audit trails for both aseptic and non-aseptic areas .

Job description

• Documentation & Document Control: Manage the complete lifecycle (preparation, issuance, retrieval, and destruction) of all QA documents, including SOPs, Logbooks, BMRs, and BPRs, while maintaining the documentation cell .
• In-Process Quality Assurance (IPQA): Conduct line clearances, perform in-process checks, and execute Acceptable Quality Level (AQL) inspections across general manufacturing, packing, and aseptic areas .
• Aseptic Area Oversight & Media Fills: Provide strict QA oversight during aseptic processing, manage aseptic process simulations (media fills), and prepare related protocols, trend reviews, and personnel tracking matrices .
• Sampling & Dispensing Verification: Oversee sample collection for commercial, submission, and validation batches, and rigorously verify the dispensing of raw and packaging materials .
• Shop-Floor Compliance & Environmental Monitoring: Ensure strict cGMP compliance through frequent shop-floor rounds, monitor environmental controls/cleanliness, and verify routine equipment printouts (CIP/SIP, Autoclaves, incubators) .
• Validation & Qualification Execution: Actively participate in the preparation and execution of Process Performance Qualifications, Cleaning Validation protocols, Hold Time studies, and Master Formula Records (MFR) .
• Product Reviews & Audit Trails: Prepare Annual Product Quality Reviews (APQR), inspect finished product consignments, manage control samples, and review equipment audit trails for both aseptic and non-aseptic areas .