Nageswara Rao
Deputy General Manager @Extrovis
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WORK HISTORY
Deputy General Manager @Extrovis
Hyderabad, IN
Responsible for the Analytical Laboratory, which includes Global stability, Analytical Method validations and transfers, Batch releases, Extractable and Leachable studies, Peptide characterizations, Genotoxic and NSA evaluations, and so on.Responsible for Microbiology Laboratory, which includes BET, MLT, In use studies, AET, etc. Responsible for Quality Assurance, which includes issuance & control, Data review, QMS implementations, Closing of Incidents and OOS, CAPA Implementation, Trainings, Regulatory and customer inspections etc.
EDUCATION
M.Sc
Master's Degree
ABOUT NAGESWARA RAO
Pharmaceutical professional with 18 years of experience in Quality control, Quality assurance and analytical research. Seasoned Quality Control (QC) Head in the pharmaceutical industry, specializing in analytical testing, GMP compliance, and regulatory audits (USFDA, MHRA, EU-GMP). Adept at leading QC teams, ensuring product integrity, and implementing advanced analytical techniques. Proven track record in method validation, stability studies, and laboratory automation, driving continuous improvement and operational efficiency. Passionate about fostering quality-driven cultures, training teams, and ensuring seamless coordination between cross functional teams. Key result areas: • Analytical Method validations/Verifications/Transfers • Conducting Laboratory Investigations • Improving QMS and performing CAPA management and Change management. • Qualification and calibration of Instruments and Computer system validations. • Planning and supervising daily activities of laboratory along with reviewing analytical documents. • Conducting audit trials review, creating Instrument methods and processing methods. • Responsible for laboratory chemicals, columns, Reference/ Impurity Standards management. • Approval of Incoming raw materials, Packaging materials and finished products as per dispatch schedules. • Compiling Stability studies and data along with coordinating with RA team for regulatory filings and deficiency responses. • Handling market complaints in coordination with cross functional departments. • Evaluating Pharmacopeial monographs and monitoring of GLP Practices in the Laboratory. • Review and approval of SOP’s, Sampling plans, STP’s, Work sheets and Certificate of Analysis. • Oversee the monitoring and control of the manufacturing environment • Continuous monitoring of material suppliers, GMP related outsourced providers. • Participate in management reviews of process performance, product quality and of the quality management system. • Oversee the control of the retention samples of materials and products. • Manage the quality control team, championing and promoting a quality culture. • Faced regulatory inspections and responded to audit observations.
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