Experience

• 

  Cipla

  Sept 2007 - Aug 2017

  Adl assistant manager

  • Engaged in method development and method validation related activity.• Planning and Conducting analytical and physical tests on raw materials, drug substances and drug products /Raw materials and was successful to reduced Turn around time by about 25%• Proficient in performing Force degradation study , Genotoxic impurities study on API drug substances by using HPLC .• Directing, leading & motivating a team of 6 members; allotting instruments & imparting continuous on job training for achieving high operational effectiveness / efficiency .• Daily verification of Instrument usage Log Book activities on daily basis and ensuring compliance to the quality system as per cGMP/ cGLP Maintaining of calibration Schedule for various instrument department• Drafting Certificate of Analysis (COA) after completion of tests according to SOP and Responsible for perform the Risk Assessment and ensure the completion of the mitigation measures• Maintaining various key documents, logbooks, databases and notebooks in compliance with cGMPs.• To perform Method validation & Method transfer at manufacturing unit. Show less

• 

  Swati spentose pvt. ltd.

  May 2019 - now

  Assistant manager qms

  • Achieving timely and effective investigation for Out of Specification (OOS) , Out of trend(OOT),Incident along appropriate root cause analysis for Quality control department.• Responsible for Handling of Deviation and Change management associated with Quality control department through QMS software and achieved about 85% efficiency of closing of QMS document within predefined timeline.• To ensure that all activity related Vendor qualification and Batch Released are completed in timely manner . Review of protocol and report for stability study & other product development studies• As a part of continues improvement system, implementation of effective CAPA to further reduce non-conformance in Quality control department by about 20% on yearly basis• Associated with Regulatory audit compliance team for delivering effective and timely compliance as per regulatory requirement.• Investigate market/ customer complaints and close it with proper CAPA• To review and Identify Gaps in standard operating procedure (SOPs) ,specifications ,MOA through DMS software and timely updation of the same as per requirements.• Periodically perform internal Audit and carry out Internal quality compliance Training .• To ensure that all activity related to Batch Released are completed in timely manner through LIMS Show less