Mukkera Thirupathi

I have experience in Quality control and Analytical Method validation of 14 years. I have proved the best during the services in the organization I have worked. I will strive hard for the betterment of the organization. Currently working in Drug manufacturing company as 'Senior Executive' in Quality control and Analytical Method Validation Department.

Senior Executive – Quality control Department at Drug Manufacturing company (2022-04 – Present)

• Monitoring a group of analysts and sample management of In-process and Finished Products
• Coordinating with core functional team like QC, QA, R&D, Production and Regulatory Affairs team for the successful release of product
• Maintain proper documentation associated with the preparation and review of analytical specifications and raw data sheets, Analytical method validation, method verification documents
• Daily audit trial verification Empower software and Open lab software
• Qualification of Alternative vendor Active Pharmaceutical Ingredients
• Provides guidance to junior members on GLP and analytical techniques (through team meetings and individual interactions)
• Maintain cGMP, GLP and Notebook keeping to satisfy regulatory affairs
• Conducts approvals/rejection of finished products and In-process samples
• Stability studies for ANDA Products and Compilation of stability data
• Review & approval of SOPs, STPs / Specifications
• Finished products Hold time study In process and Process Validation samples allocation to group members
• Preparation of certification of analysis (COA) for finished products
• Calibration of analytical instruments such as HPLC, GC, IR, UV, and KF
• Maintain entire quality control operations ensuring quality parameters for the tablets, capsules, suspensions, dry powder and injectable dosage forms
• Indenting Chemicals, Columns, Reference standards (USP/EP) and Impurity standards and follow up
• Interacting with other departments for review, evaluation and proper closure of deviation, incidents, CAPA, OOS, OOT and change control
• Highly experienced with HPLC troubleshooting and maintenance
• Regular lab maintenance and daily work scheduling, Ensuring Safety compliance in lab
• Responsible for charging and withdrawal of stability samples and maintenance of stability chambers
• Successful Coordination for the various audits like US FDA, EDQM, MHRA and Customer audits
• Preparing the training modules based on the review outcomes and conduct training to the quality control personnel to improve laboratory compliance

Analytical Scientist-II – Analytical Method Validation Department at Aurobindo Research Center-I (2016-04 – 2022-04)

Executive – Quality control and validation at Graviti pharma (2014-02 – 2016-03)

Analyst – Quality control and R&D at Zenara pharma (2011-07 – 2014-02)

B.Pharmacy in Pharmacy – Kakatiya University (2008)

M.Pharmacy in Pharmacy – Kakatiya University (2011)