QA Sterile - Deputy Manager

USV PRIVATE LIMITED; Daman; On-site; INR 400,000 - 800,000; Full time

Job summary

USV PRIVATE LIMITED is seeking a QA professional to oversee documentation control, IPQA activities, aseptic area oversight, and sampling/dispensing verification across manufacturing and packaging lines.

The role includes maintaining cGMP compliance, performing environmental monitoring, and participating in validation/qualification studies, with involvement in product reviews and audit trails. Prior experience in aseptic environments is advantageous.

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 .