Sr. Officer - QA

Drlogy; Ahmedabad District; On-site; INR 400,000 - 600,000; Full time

Job summary

Drlogy is seeking a Sr. Officer – QA responsible for overseeing quality assurance activities, reviewing batch documentation, and ensuring adherence to quality standards in Ahmedabad, India. The ideal candidate will conduct in-process checks, perform sampling, and coordinate with teams to address quality issues, supporting continuous improvement initiatives and compliance with regulations such as USFDA and WHO.

Responsibilities

• Perform detailed review of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
• Provide line clearance for manufacturing and packing areas.
• Conduct in-process checks during manufacturing and packing stages.
• Perform sampling of raw materials, in-process, bulk, and finished products.
• Execute AQL sampling during packaging operations.
• Monitor shop-floor activities to ensure compliance with cGMP and GDP.
• Verify equipment cleanliness and calibration status before production.
• Ensure proper documentation and real-time recording of quality-related data.
• Coordinate with Production, QC, and Engineering teams for quality issues.
• Support investigation of deviations and implement CAPA.
• Ensure adherence to SOPs and regulatory guidelines such as USFDA and WHO.
• Participate in internal audits and ensure audit readiness.
• Maintain proper documentation for sampling and in-process checks.
• Identify areas for process improvement and support quality enhancement initiatives.
• Ensure compliance with safety, hygiene, and quality standards.

Job description

The Sr. Officer – QA will be responsible for overseeing in-process quality assurance activities, reviewing batch manufacturing and packing records, and ensuring that all production and packaging operations comply with established quality standards and regulatory guidelines. The plays a critical part in maintaining product quality, data integrity, and audit readiness across manufacturing processes.

Roles and Responsibilities

• Perform detailed review of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) to ensure accuracy, completeness, and compliance with SOPs.
• Provide line clearance for manufacturing and packing areas, ensuring removal of previous batch materials and prevention of cross-contamination.
• Conduct in-process checks during manufacturing and packing stages to ensure adherence to defined specifications and procedures.
• Perform sampling of raw materials, in-process, bulk, and finished products as per approved sampling plans.
• Execute AQL (Acceptable Quality Level) sampling during packaging operations to ensure product quality and compliance.
• Monitor shop-floor activities to ensure compliance with cGMP, GDP, and data integrity requirements (ALCOA+ principles).
• Verify equipment cleanliness, calibration status, and readiness before use in production.
• Ensure proper documentation practices and real-time recording of data in all quality-related records.
• Coordinate with Production, QC, and Engineering teams to address quality-related issues and deviations.
• Support investigation of deviations, OOS, OOT, and implementation of CAPA.
• Ensure adherence to SOPs, quality policies, and regulatory guidelines such as USFDA, WHO, and EU-GMP.
• Participate in internal audits, regulatory inspections, and ensure audit readiness of the department.
• Maintain proper documentation for sampling, in-process checks, and line clearance activities.
• entify areas for process improvement and support continuous quality enhancement initiatives.
• Ensure strict compliance with safety, hygiene, and quality standards on the shop floor.