Rammanohar Mishra

Experience

• 

  Ipca Laboratories Limited

  Dec 2006 - Jan 2008

  Chemist

  IPQA ACTIVITY

• 

  Panacea Biotec Ltd

  Jan 2008 - Aug 2009

  Officer

  IPQA ACTIVITY

• 

  Ranbaxy

  Aug 2009 - Jul 2011

  Sr. Officer

  IPQA/ COMPLIANCE

• 

  SUN PHARMA

  Jul 2011 - Nov 2014

  Sr Officer

  Handling of IPQA/ Compliance/ Investigation

• 

  Mylan Laboratories Limited

  Nov 2014 - now

  • Review & approval of Validation protocol & report, like Equipment Qualification, process validation,Cleaning validation etc• Preparation, Review and control of documents viz. Manufacturing Records, Technical Directions, Master Formula Record, Specification and Standard Test Procedures. • Conduct facility qualification activities like; Water system validation, HVAC system validation,Compressed Air system.• Review & approved the NDA & ANDA Document like – protocol & report of Scale up batch, Exhibit Batch, process validation & cleaning Validation, Hold time Study ).• Document compilation and furnishing the document for Regulatory Submission.• To conduct & execute the Self Assessment & Internal Audit & make a compliance report against audit reports.• Preparation & Participation in various external audits in the company• Preparation and Review of documents like Validation Master Plan, Site Master File, Quality Manual etc• Involved in Document and Data Control.• Batch records review and release.• Preparation of CAPA reports, handling the corrective/preventive action (CAPA) to ensure timelyimplementation of CAPAs.• Handling of quality system documents like; OOS and OOT documents, Change Control,deviations, non-conformances, Root Cause Analysis, Laboratory investigations.• Involvement in Retrospective validation and trend analysis.• To check standard (GMP) compliance at shop floor during routine visits.• Conduct on job and GMP trainings. Show less

  • Quality Assurance Deputy Manager at Mylan Laboratories Limited

    Mar 2017 - now

  • Quality Assurance, Assistant Manager

    Nov 2014 - now