Nakkina Apparao

Senior Quality Control professional with over 28 years of experience in API pharmaceutical manufacturing and Quality Control laboratory management. Demonstrated strong leadership in managing large QC teams while ensuring strict adherence to cGMP, ICH guidelines, and data integrity principles.

Assistant General Manager – API-Unit7 Site Quality Control at Matrix Pharma Corp (previously Viatris / Mylan Laboratories) (2016-12 – 2026-03)

• Spearhead end-to-end Quality Control operations for API and intermediates, overseeing both wet chemistry and advanced instrumental analysis.
• Drive strategic laboratory management, including analytical planning, resource allocation, and batch release oversight, to ensure uninterrupted production timelines.
• Lead complex OOS, OOT, deviation, and incident investigations by applying structured root cause analysis methodologies and implementing robust Corrective and Preventive Actions (CAPAs).
• Ensure continuous regulatory compliance with USFDA, WHO-GMP, and ICH guidelines, maintaining the laboratory in a constant state of inspection readiness.
• Govern the lifecycle management of working standards, reference standards, and impurity samples to ensure complete traceability and documentation integrity.
• Direct the calibration, qualification, and preventive maintenance programs for a wide range of analytical instruments, including HPLC, GC, IR, and UV-Vis systems.
• Provide technical leadership for Drug Master File (DMF) documentation, regulatory submissions, and ICH Q1A stability programs supporting global market registrations.
• Orchestrate QC laboratory preparations for USFDA inspections and international customer audits, successfully achieving the closure of all observations with zero repeat findings.
• Champion ALCOA+ data integrity principles across all QC operations, implementing system-level controls within LIMS and SAP Quality Management modules to ensure audit-proof documentation.

Resource Manager - Quality Control at Dr. Reddy's Laboratories (1997-12 – 2016-11)

• Managed comprehensive wet chemical and instrumental analysis for raw materials, intermediates, and finished API products across a high-volume pharmaceutical manufacturing environment.
• Designed and executed analytical testing plans aligned with production schedules, ensuring timely and accurate results to support batch disposition decisions.
• Conducted thorough OOS, OOT, and incident investigations, applying ICH and cGMP principles to identify root causes and determined effective, sustainable corrective actions.
• Maintained meticulous QC laboratory documentation, reference standard inventories, and analytical records in full compliance with global regulatory expectations.
• Executed cleaning validation, process validation, and in-process reaction monitoring studies, providing critical analytical support to manufacturing and process development teams.
• Collaborated closely with regulatory affairs and production teams during regulatory inspections and customer quality audits, contributing to consistently favorable outcomes over a 19-year tenure.

M.Sc. in Pharmaceutical Chemistry – Birla Institute of Technology (2004 – 2007)

B.Sc. in Chemistry – Andhra University (1994 – 1997)