Venkata Rao

Dynamic and result-oriented Quality Control professional with 30+ years of extensive experience in pharmaceutical API industries. Seeking to work as a Dy.

General

Manager (Quality Control) in a dynamic and growth-oriented pharmaceutical organization where I can effectively utilize my extensive experience in Quality Control operations, regulatory compliance, laboratory management, and team leadership. Committed to strengthening quality systems, ensuring compliance with cGMP and global regulatory requirements, driving continuous improvement initiatives, and contributing toward organizational excellence through effective planning, implementation, and maintenance of robust quality standards.

Dy. General Manager-QC at Matrix Pharmacorp Pvt. Ltd. (2010-09 – Present)

• Ensure compliance with cGMP, GLP, USFDA, MHRA, WHO, EU GMP, ICH, and company quality systems.
• Supervise analytical testing of raw materials, packing materials, in-process, finished products, cleaning samples, stability samples, and validation samples.
• Ensure all laboratory activities are performed in compliance with approved specifications, SOPs, STPs, and regulatory guidelines.
• Review and approve analytical data, laboratory notebooks, raw data, COAs, protocols, reports, and analytical worksheets.
• Monitor daily laboratory activities and ensure timely completion of sample analysis to meet production and release timelines.
• Handle OOS, OOT, deviations, laboratory incidents, change controls, and CAPA investigations.
• Perform root cause analysis and implement effective corrective and preventive actions.
• Ensure timely calibration, qualification, and preventive maintenance of laboratory instruments and equipment.
• Review instrument qualification documents including IQ, OQ, PQ, and calibration records.
• Coordinate analytical method validation, verification, transfer, and cleaning validation activities.
• Ensure proper execution and monitoring of stability studies as per ICH guidelines.
• Review stability protocols, reports, trend analysis, and stability summary data.
• Coordinate and support regulatory inspections, customer audits, and internal quality audits.
• Respond to audit observations and ensure effective closure of compliance gaps.
• Monitor laboratory compliance related to data integrity and computerized system requirements.
• Ensure implementation and adherence to ALCOA+ principles in laboratory documentation.
• Approve SOPs, specifications, protocols, reports, standard test procedures, and analytical methods.
• Review and approve qualification documents, validation documents, and technical reports.
• Monitor laboratory investigations and ensure timely closure with proper documentation.
• Ensure availability of qualified analysts for smooth laboratory operations.
• Conduct training programs for QC analysts, chemists, and section heads on GMP, GLP, safety, and analytical techniques.
• Evaluate analyst competency through periodic assessments and qualification programs.
• Monitor laboratory inventory, procurement planning, and vendor qualification activities.
• Ensure proper handling, storage, issuance, and standardization of reference standards and reagents.
• Review environmental monitoring and water analysis reports where applicable.
• Coordinate with QA, Production, Warehouse, Engineering, and Regulatory Affairs departments for cross-functional activities.
• Participate in quality review meetings and management review discussions.
• Ensure implementation of laboratory safety procedures and compliance with EHS requirements.
• Drive continuous improvement initiatives for laboratory efficiency, compliance, and productivity.
• Monitor analytical turnaround time and implement systems to improve operational excellence.
• Ensure proper archival and retention of laboratory records and raw data.
• Support regulatory submissions by providing analytical documents and technical justifications.
• Review and approve vendor qualification documents and external laboratory agreements.
• Manage laboratory budgets, manpower planning, and resource allocation effectively.
• Ensure compliance with data backup, electronic records, and audit trail review procedures.
• Maintain readiness of the QC laboratory for regulatory inspections at all times.

Manager- QC at M/s Metrochem API Pvt LTD (2009-09 – 2010-08)

Assistant Manager-QC at M/s Neuland Laboratories LTD (1995-05 – 2009-09)

MSc