Bommareddy Sreedhar Reddy

Background

About Bommareddy Sreedhar Reddy

 Certified auditor in carrying out audits as QC SME for both vendor quality management and external manufacturing teams during external audits.  Self-inspections at internal QC’s for “Any time audit readiness”.  Lead auditor for qualification / re-qualification of external manufacturing / testing laboratories.  Audit trail log review related to chromatography spectroscopy standalone instruments etc.  Subject matter expert (SME) in harmonizing QC procedures / systems.  Performing GEMBA walks at QC for compliance improvement.  Handling of Regulatory / Customer Audits.  Review of OOS / OOT / Incident investigations related to API’s and Formulation’s and provide technical guidance in identifying the assignable cause before performing retesting.  Providing technical support during regulatory inspections across API (CTO’s) and Formulations (FTO’s) sites.  Provide technical support in addressing day to day method issues related to routine sample analysis across CTO’s and FTO’s.  Providing support during harmonization of QC procedures across all sites.  Practical knowledge on handling of LIMS software.  Resolution of analytical issues related to customer complaints.  Monographs compliance review and providing gap assessment to QC’s.  Review of calibrations procedures as per the current regulatory requirements.  Providing technical support while providing DMF deficiency response.  Overall practical experience in all sections of QC starting from raw materials to Finished product including stability section.  Provide technical guidance for smooth transferring of analytical methods across different sites by identifying the gaps in methods before start of method transfer.  Provide suitable technical trainings for fresher’s in-coordination with concerned QC departments.