Swathi Nayak Email and Phone Number

Quality Assurance Executive

Regulatory affairs:Preparation and review of IND individual dossier documentsEnsuring The Safety ,efficacy and quality of the drug.Ensuring The Appropriateness And Accuracy Of Drug Information.Compliance adherence with all cGMP, GLP, GCP, ICH guidelines, Review Of Stability Reports,Raw data sheets,training files,SOPs.Review Of Specifications And Test Methods Of DrugsubstanceReview of Certificate of analysis and Results of Analysis related to GMP.Review Of Stability Protocols And Summary Reports.Review of Master And Executed batch manufacturing records.Supporting during audits from customer,regulatory,Internal Audits And Trainingmanagement.Handling Of Change controls,Handling of Deviations,investigation reportsCo-ordination during the Internal Audit of DS functionPreparation and review of SOPs and Guideline to inline with global regulatoryrequirements.Issuance,control,archival and retrieval of documents(Document management).Maintenance of the compactor(Archival)

I have experience in research and development for an year and worked as department which is Development Quality assurance and CMC RAReview individual dossier leaves, Review Of Stability Reports,raw data sheets,training files,SOPs.Review Of Specifications And Test Methods Of Drugs substanceReview of Certificate of analysis and Results of Analysis related to GMP.Review Of Stability Protocols And Summary Reports.Review Of Master And Executed Batch Manufacturing Records.Supporting during audits from customer, regulatory, Internal Audits And Trainingmanagement.Handling of Change controls,Handling Of Deviations,investigation reportsCo-ordination during internal Audit of DS functionPreparation and review of SOPs and Guideline to inline with global regulatoryrequirements.Issuance,control,archival and retrieval of document's(Document Management).Maintenance Of The Compactors(Archival)