Ramanamurthy Kondeti

About Ramanamurthy Kondeti

Lean six Sigma green belt certified and Result Oriented Quality Professional lead having more than 15 years of technical expertise and skills in the regulated pharmaceutical who worked in both Quality control and Quality Assurance departments. Currently, heading as a Lab Head complete (In-process, Batch Releases, Stability, Centralized Standard Qualifications & Inventory management, QMS Events, Instrument Qualifications and calibrations, Audit Management & Lab compliance, Regulatory Audits, Queries/Responses, Market Complaints, Risk & Impact Assessments, Change Controls, GAP Analysis, Risk Assessments & Mitigation plans, Effective CAPA implementations, Ensuring the Data Integrity, Trainings & Mentoring and etc. In addition to that, Handled Internal & external Audits, Worked as a Co-auditor at UK & Europe for contract testing laboratories, Handled Market Complaints, QMS related events & CAPA implementations, Trained QRM member, Handled Laboratory CSV activities, Handled FDA & MHRA Audits as a Quality Assurance SME Team Lead and etc. Planning and execution of the complete laboratory activities to meet the specific regulatory guidelines and compliance. Acquired sound knowledge and technical experience on various QC instruments HPLC, UHPLC, GC, Dissolution, UV, and AAS. Handled various software’s: LIMS, Trackwise, Empower, chromeleon and etc. Currently, I am responsible and accountable for complete Analytical laboratory activities and effectively handling, guiding, mentoring and providing the inputs/suggestions with respect to the complete lab. Qualifications, Equipment Qualifications, Lab Compliance, Quality Management System, Regulatory

Experience

1. Manager

   Biocon Biologics

   Aug 2019 — Present · Bengaluru, IN

   Worked in both “Quality control and Quality Assurance” departments. Result-oriented smart working Quality Professional lead having more than 14 years of technical expertise in the regulated pharmaceutical industries with In-process, Finished Products (Batch Releases), Stability testing as per the schedules, Centralized Standard Qualifications & standard management, QMS Events (Investigations), Lab compliance, Regulatory Audits, Queries/Responses, Market Complaints, Risk & Impact Assessments, Change Controls and etc. Planning and execution of the complete laboratory activities to meet the specific regulatory guidelines and compliance.Acquired sound knowledge and technical experience on various QC instruments HPLC, UHPLC, GC, Dissolution, UV, and AAS. Handled various software’s: LIMS, Trackwise, Empower, chromeleon and etc.Currently, I am responsible for Bio-Analytical laboratory activities and effectively handling, guiding, mentoring and providing the inputs/suggestions with respect to the In-Process, Finished Product, Stability, Standard Qualifications, Equipment Qualifications, Lab Compliance, Quality Management System, Regulatory Audits, Internal & External Audits, Customer Audits, Audit Queries & Responses, GAP Analysis, Risk Assessments & Mitigation plans, Effective CAPA implementations, Change controls, Deviations, OOS/OOT, Incidents, Ensuring the Data Integrity, Market complaints & Responses, Trainings & Mentoring and etc.In addition to that, Handled Internal & external Audits, Worked as a Co-auditor at UK & Europe for contract testing laboratories, Handled Market Complaints, QMS related events & CAPA implementations, Trained QRM member, Handled Laboratory Equipment Qualifications, Handled FDA & MHRA Audits as a Quality Assurance SME Team Lead and etc.

Education

• Vellore Institute of Technology

  Master of Science (M.Sc.)

  2005 — 2007