Venkateswararao V

Quality Assurance Associate Manager with 10+ years of progressive experience in global biopharmaceutical operations across Sandoz, Novartis, Dr. Reddy's Laboratories (DRL) and Biocon. Expertise in GxP compliance, pharmaceutical quality systems (PQS), batch disposition and product release for EU and APMA markets.

Skilled in quality risk management (QRM), CAPA, deviation management, change control, supplier qualification, and regulatory inspection readiness. Strong record of managing 60+ Contract Manufacturing Organizations (CMOs) and 1,200+ commercial batch reviews annually with zero critical compliance findings. Proficient in SAP (QM, PM), Trackwise, VeevaRIM, QlikSense, and Power BI for data analytics and quality governance.

Recognized for driving continuous improvement, SLA/FTE performance optimization, and ensuring compliance in complex, multicultural environments.

QA Associate Manager – Global Operations at Sandoz Limited (Internal Transfer from Novartis) (2023-05 – 2025-08)

• Responsible for timely Compilation and review of required batch release documentsfor compliance and quality for all third-party contract manufactured products for which Sandoz/Novartis is the Marketing Authorization holder or acts as a distributor for the release of products to Europe market.
• Quality review of Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), API documents (FDF and Supplier), DMF/CEP changes, and EU regulatory variations to ensure ongoing compliance for every batch.
• Data verification in SAP (QM, PM), VeevaRIM, Trackwise, GxQEM and Preparation of batch certification (CoC) for Qualified Person (QP) authorization, Certificate of Analysis (CoA) and complete checklist for batch release based on the market requirements.
• Ensure that documents are in full compliance with GMP, and regulatory standards and subsequent results recording in SAP for timely batch release.
• Responsible for timely updation of batch release tracker/dashboards associated with batch release activity for batch release governance.
• Coordinate with third party manufacturing sites and internal stakeholders for obtaining required documents for release of batches in European market.
• Escalate any non-conformance/delay associated with batch release documents compilation to Global Batch Release team/ Qualified Person (QP).
• Served as Quality Focal Point (QFP) for 60+ CMOs and suppliers supporting EU markets, ensuring uninterrupted product supply, cGMP compliance, and adherence to regulatory requirements.
• Oversaw batch disposition and product release operations for 1,200+ commercial batches annually across APMA and EU markets, achieving zero critical compliance findings while meeting all QAA and PSA requirements.
• Monitored quality KPIs, led annual quality evaluations (Annual Product Quality Reviews), and implemented corrective actions contributing to ~80% reduction in recurring deviations year-over-year.
• Led Service Level Agreements (SLA) and Full Time Employee (FTE) performance monitoring across the quality operations team, driving resource optimization and continuous improvement initiatives.
• Developed QlikSense dashboards to enhance quality data visibility, enabling data-driven decision-making at leadership governance calls.
• Managed change control and deviation management processes using Trackwise, Agile, and GxQEM (Salesforce), ensuring timely closure within SLA targets.
• Authored and maintained SOPs, Work Instructions (WI), and transition documents to strengthen the pharmaceutical quality system (PQS) and document control.
• Supported regulatory inspections and internal QA audits; led proactive inspection readiness initiatives and resolved compliance gaps.

QA Specialist – Global Operations at Novartis Limited (2020-11 – 2023-04)

• Responsible for timely Compilation and review of required batch release documentsfor compliance and quality for all third-party contract manufactured products for which Sandoz/Novartis is the Marketing Authorization holder or acts as a distributor for the release of products to Europe market.
• Quality review of Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), API documents (FDF and Supplier), DMF/CEP changes, and EU regulatory variations to ensure ongoing compliance for every batch.
• Data verification in SAP (QM, PM), VeevaRIM, Trackwise, GxQEM and Preparation of batch certification (CoC) for Qualified Person (QP) authorization, Certificate of Analysis (CoA) and complete checklist for batch release based on the market requirements.
• Ensure that documents are in full compliance with GMP, and regulatory standards and results recording in SAP for timely batch release.
• Coordinated end-to-end service transitions, incorporating SLA monitoring, Data Integrity (DI) checks, and FCM compliance protocols.
• Acted as Quality SPOC for CMOs and suppliers, resolving deviations, investigating OOS/OOT results, and supporting regulatory approvals.
• Responsible for timely updation of batch release tracker/dashboards associated with batch release activity for batch release governance.
• Coordinate with third party manufacturing sites and internal stakeholders for obtaining required documents for release of batches in European market.
• Escalate any non-conformance/delay associated with batch release documents compilation to Global Batch Release team/ Qualified Person (QP).
• Served as Quality Focal Point (QFP) for 60+ CMOs and suppliers supporting EU markets, ensuring uninterrupted product supply, cGMP compliance, and adherence to regulatory requirements.
• Oversaw batch disposition and product release operations for 1,200+ commercial batches annually across APMA and EU markets, achieving zero critical compliance findings while meeting all QAA and PSA requirements.
• Monitored quality KPIs, led annual quality evaluations (Annual Product Quality Reviews), and implemented corrective actions contributing to ~80% reduction in recurring deviations year-over-year.
• Led Service Level Agreements (SLA) and Full Time Employee (FTE) performance monitoring across the quality operations team, driving resource optimization and continuous improvement initiatives.
• Developed QlikSense dashboards to enhance quality data visibility, enabling data-driven decision-making at leadership governance calls.
• Managed change control and deviation management processes using Trackwise, Agile, and GxQEM (Salesforce), ensuring timely closure within SLA targets.
• Authored and maintained SOPs, Work Instructions (WI), and transition documents to strengthen the pharmaceutical quality system (PQS) and document control.
• Supported regulatory inspections and internal QA audits; led proactive inspection readiness initiatives and resolved compliance gaps.

QA Specialist – Global Operations at Novartis Limited (2020-11 – 2023-04)

• Responsible for timely Compilation and review of required batch release documents for compliance and quality for all third-party contract manufactured products for which Sandoz/Novartis is the Marketing Authorization holder or acts as a distributor for the release of products to Europe market.
• Quality review of Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), API documents (FDF and Supplier), DMF/CEP changes, and EU regulatory variations to ensure ongoing compliance for every batch.
• Data verification in SAP (QM, PM), VeevaRIM, Trackwise, GxQEM and Preparation of batch certification (CoC) for Qualified Person (QP) authorization, Certificate of Analysis (CoA) and complete checklist for batch release based on the market requirements.
• Ensure that documents are in full compliance with GMP, and regulatory standards and results recording in SAP for timely batch release.
• Coordinated end-to-end service transitions, incorporating SLA monitoring, Data Integrity (DI) checks, and FCM compliance protocols.
• Acted as Quality SPOC for CMOs and suppliers, resolving deviations, investigating OOS/OOT results, and supporting regulatory approvals.
• Strengthened quality management processes through improved document control, SOP authoring, and post-submission change management.
• Participated in EMA, EU regulatory authority, and internal QA inspections; ensured ongoing audit readiness and inspection preparedness.

Assistant Manager – Manufacturing, Biologics at Dr. Reddy's Laboratories (DRL) (2017-01 – 2020-06)

• Led commercial-scale GMP manufacturing of biopharmaceuticals and biosimilars (Rituximab, Trastuzumab, PEG-GCSF) using mammalian cell culture (up to 1KL) and microbial fermentation (up to 200L).
• Ensured cGMP compliance in upstream biopharmaceutical operations, enhancing yield, process consistency, and regulatory readiness.
• Prepared and reviewed SOPs, BMRs, validation protocols, and deviation reports; acted as QMS SPOC for all production documentation.
• Directed equipment qualification and requalification programs (DQ, IQ, OQ, PQ), process validation, and cleaning validation activities.
• Supported regulatory inspections (Ukraine Health Authority, DCGI, Global QA Novartis), ensuring inspection readiness and hosting auditors.
• Implemented quality risk management (QRM) assessments and process improvement initiatives, enhancing operational efficiency and compliance.

Executive / Trainee – Manufacturing, GPP Biologics at Biocon Limited (2015-01 – 2017-01)

• Conducted large-scale GMP production of biosimilars (Streptokinase, G-CSF, PEG-GCSF) in regulated biopharmaceutical facilities.
• Performed inclusion body purification and upstream process operations, maintaining cGMP standards and quality specifications.
• Prepared SOPs, BMRs, and deviation reports; initiated change control and investigation protocols.
• Supported FDA, DCGI, and LabPisa regulatory audits with accurate GMP documentation and inspection readiness.
• Developed and maintained Working Cell Banks (WCBs) in GMP facilities, ensuring process reproducibility and compliance.

Junior Research Fellow at Kumaraguru College of Technology (2013-07 – 2014-06)

• Developed immobilized protease-based wound dressing materials; research applied to biomedical and pharmaceutical applications.

M.Tech in Industrial Biotechnology – SASTRA University (2009 – 2011)

B. Tech in Biotechnology – SRM University (2004 – 2008)