Nagamallaiah Podendla

Experienced professional with over 13 years of expertise in QMS, QC, Stability Studies, Method Transfers, Analytical Assurance, Computer System Validation, and Lab Compliance functions across global markets including the US, Canada, Europe, Australia, and ROW. Actively participated in various regulatory audits with real-time experience. Proven track record in QMS investigations, Analytical Assurance, Method Transfer activities, and Compliance. Skilled in streamlining processes and procedures to enhance the robustness of QMS and implementing quality measures for operational efficiency. Highly motivated and results-oriented individual with a proactive approach, efficiency, and a strong desire to work in the pharmaceutical industry to stay updated on emerging trends and latest technologies for continuous knowledge expansion.

QMS Investigations-Out of Specifications, Out of trends, CAPA, Quality control-Training, Stability studies, Method transfers, Method validation, Lab Compliance, Audit trials and Lab Equipment IQ,OQ and PQ.

Familiar with software’s like, Caliber LIMS and E- LIMS. Management of change controls and CAPA in Meatricstream. Familiar with scientific applications of advanced software’s for the complete management of HPLC like Empower 3, chromeleon, Tiamo and UV-Probe.

• Well versed in handling of analytical related OOS,OOT and incidence investigations, Registration of the OOS/OOT investigations and assisting in investigations.
• Deriving recommended actions and concluding findings of investigation.
• Review of lab Non conformance summary reports like OOS, OOT and Analytical Incidences.
• Responsible for Initiating CAPA based on the type of OOS/OOT observed and ensuring effective implementation of CAPA. Instruments and System Qualification documents Review.
• Responsible for Lab commissioning and improvement of laboratory systems.
• Responsible for Computer System validation protocols and reports review
• Responsible for CAPA management and Change management procedures (Change control).
• Responsible for receiving and conducting Analytical method transfers from R&D.
• Responsible for preparation of OOS\OOT trends.
• Conducting periodic audits – QC and cross functional departments.
• Review of analytical reports like Finished product, Raw materials, Validation, Stability, and Packaging material.
• Technical training and evaluation of Quality control personnel, further continuous training for the quality systems improvements & changes and skill level enhancement, Periodic cGMP trainings.
• Ensuring the safety of laboratory and personnel through best GLP practices.
• Hands-on and Practical experience on various sophisticated advance analytical instruments like UPLC, HPLC, Gas Chromatography, UV-Spectrophotometer, Auto Titrator, IR etc.
• Trouble shooting, Planning, Implementing and prioritizing Quality Control Systems and jobs as per Plant. requirements w.r.t. in process materials and Finished Products in coordination with Production, Warehouse and QA.
• Audit trial verification of laboratory instruments.