Arunkumar Venkatesan Email & Phone Number

Reykjavík, Capital Region, Iceland

Expertise in review and approval of ARD and QC documents such as Method development and method Validation and method transfer protocols and reports, Batch release data. Expertise in CSV protocols review and approval as per Agile methodology and GAMP 5 EU annexure 11.

Bengaluru, Karnataka, India

Good exposure to establishing a new Pharma DS and DP testing laboratory as per 21 CFR part 210, part 211 part 11 Regulations.Certified Trainer on ALCOA++ to prevent DI.Good knowledge and exposure in ISO:9001, ISO:17025 standards, ICH, USP chapters. Demonstrates excellence in Quality Compliance (LIMS, QMS, DMS, ERP, BioNet and SAP.Review and approval of Quality related SOP’s based on current regulatory standards on need basisGood knowledge in specifications review and approval of RM, PM, INT and FP and Batch release data, Analytical method validation, analytical method verification, Forced degradation study, stability study, standard qualification data.Review and approval of instrument Qualification protocols and reports as per GAMP 5 V-model approach and CSV.Execution in leading pharmaceutical operations of Analytical method validation, analytical method transfer, Batch analysis, stability study pertaining to Formulation products, API and Biologicals (DS and DP).

India

Exhibit leadership capabilities in leading pharmaceutical operations of Analytical method validation, analytical method transfer, Batch analysis, stability study pertaining to Formulation products, API and Biologicals (DS and DP).Expertise in Quality Management System (QMS): Change control, Deviation, LIR, OOS, OOT and CAPA.Gained Significant knowledge/exposure on Formulation, API and Biologicals testing activities.Leading, mentoring & monitoring the performance of team members to ensure an efficiency in process operations and Meeting of individual & group targets.Certified Trainer on ALCOA++ to prevent DI.Demonstrates excellence in Quality Compliance (LIMS, QMS, DMS, Nichelon and SAP).Adopting Six sigma Lean principles for ensuring analytical methods without affecting the productivity.Progressive history of driving technology transfers of analytical methods between laboratories of regulatory pharmaceutical company (OL and RL).Successfully faced major regulatory audits i.e. Local FDA, USFDA, customer audits national and international.Acted as SME in QMS Investigations and analytical data review during USFDA audits and other regulatory audits and customer audits.Credentials in review of analytical method validation, batch release, stability study data, method verification, FD, method transfer & method development protocols and reports.Review of instrument Qualification protocols and reports as per GAMP 5 V-model approach and CSV.

Bangalore

Result oriented professional with about 9 years of experience in the Quality Domain (GMP and Lead role in system implementation in a global CRO environment). Successfully managed multiple external (sponsor/third party) audits acting as QA lead.Leading An Analytical Quality Assurance review team: In-process data, Analytical method validation, analytical method verification, Forced degradation study, stability study, standard qualification and Instrument/Equipment Qualification.Involved in multiple process development investigation pertaining to user test trails and usage of the materials with necessary CAPAPlaning and executing the analytical activitesInvolved in multiple regulatory Audits including USFDACertified internal Auditor Responsible for Non Rountine Activities _ Analytical method Validation, FD study, Analytical method Development, stability study, instrument qualifications and standard qualifications etc.Review and Approval of the following documentsAnalytical method validation, FD study and method development dataQC, BG-QC, BG-ARD and ARD-Instrument QualificationsBatch relaese data and Specifications such as RM,PM,CLS,IPC,INT & FPMethod transfer protocol, data and Reports (Direct and indirect transfer)Working/Reference standards protocol, data and reportsStability study Protocol data and ReportsValidation study protocols and ReportsForced degradation protocols and reports QMS: Handling and closure of deviation, Non confirmity, Laboratory incident, Change controls and OOS etc..,Review and approval of instrument Qualification protocols and reports as per GAMP 5 V-model approach and CSV.

Bengaluru Area, India

Review and Approval of analytical data and reports for Biologics, API, Formulation.Review and Approval of the following documentsRM/PM analytical reports Specifications - RM,PM,CLS,IPC,INT & FPMethod transfer protocol/ReportsWorking/Reference standards protocol/reportsStability study Protocol/ReportsValidation study protocols/ReportsHandling and closure of deviation, incident, Change controls and OOS etc..,IOP, SOP & Issuance etc..,

Puducherry

Handling work experience on instruments HPLC,GC UV,DT,Friability, IR,SOR, NIR, DSC, KF, pH, etc...

M.Sc, Biotechnology

B.Sc, Biotechnology