Santosh G. Email and Phone Number

Working as internal audit coordinator :Prepare and circulate yearly and monthly schedule, prepare list of trained and qualified auditors and subject matter expert, prepare dynamic checklist by considering cGMP, GDP, GLP, data integrity etc guidelines, communicate agenda of audits to auditors, prepare internal audit compliance status verification report, ensure timely completion of audit process, prepare and circulate annual executive summary report, conduct additional audits of new departments, maintain documents of internal audit, represent the internal audit system in external audits, initiate the process of qualification of new auditors, revision and training on SOP of Internal audit system, impart training on Internal audit system in monthly cGMP training.Team member of OOS and OOT investigation :Prepare acknowledgement report of OOS and OOT intimation, timely initiate and complete the investigation by going to on site of incidence and review of related documents, prepare OOS and OOT investigation report with recommendation and issue CAPA to respective department, follow up CAPA as per respective target completion date (TCD), Verification of deviation, etc.Review of Stability and Analytical method validation protocol, report and raw data of various Vaccines/Biosimilars.Line clearance of filling, packing and raw material dispensing.As an internal auditor, participate in the audit process of various department such as production, blending, filling and quality control.Preparation and revision of SOPs in eDMS by following change control system and annual review of SOPs. Faced audits such as USFDA, MHRA, TGA, Health Canada, CDSCO, WHO, Local FDA and various ministry of health of different countries, consultants of various countries/companies.

Involved in the analytical method development of methods required for the analysis of Bevacizumab and Adalimumab inprocess samples.Handled team of 19 people to handle products like; Tenecteplase, Erythropoietin, Sargramostim, Filgrastim, Pegfilgrastim, and Pegaspargase.Document review through change control related to regular In process, Semi finish, Final bulk and Finish product analysis of Erythropoietin (As per Ph.Eur./IP/BP), Tenecteplase (As per in-house specification), Filgrastim (As per Ph.Eur./IP), Sargramostim (As per in-house specification), Pegfilgrastim (As per in-house specification/IP) and Pegaspargase (As per in-house specification).Handled of regulatory, QA related queries and troubleshooting of analytical problems in day to day working.Handled of discrepancy, out of specification, out of trend, deviation etc. Involved in process and cleaning Validation Involved in the stability related activitiesInvolved in preparation and execution of Internal standard and system suitability for Tenecteplase, Sargramostim, Pegfilgrastim and Pegaspargase. SAP related activities. Involved (partly and fully) in the method validation of routinely used techniques such as ELISA, SDS-PAGE (Silver and coomassie staining), Immunoblotting, IEF, Host cell protein, Host cell DNA, Dimers and related substances of higher molecular mass, Monomer and Single chain content by SE-HPLC, Peptide mapping, Related proteins by RPHPLC, estimating glucose content by glucose oxidase method, estimating protein concentration by Optical Density at 280 nm, Lowery and Bradford.Involved fully in the Validation of Bioactivity by clot lysis method for Tenecteplase.Involved partly in the Validation of Bioassay method for Sargramostim, Filgrastim and Pegfilgrastim (by cellular proliferation assay).Calibration of instrumentsFaced audits such as FDA, CDSCO, WHO, various ministry of health of different countries, consultants of various countries/companies.

Analysis of both Tablet and Injection.In tablets, tests were performed like dissolution, friability (Tablet friability tester: By Electrolux ), hardness, thickness, diameter (Tablet hardness, thickness and diameter tester: By Erweka), impurities , related substances, uniformity of dosage unit , uniformity of content and assay by HPLCIn injection, I tests were performed like water content measurement (Karl-Fischer titrator : By Metrohm) , pH measurement (pH meter : By Thermorian) , impurities , related substances, uniformity of dosage unit , uniformity of content and assay by HPLC