HOD Quality Control API with M.Sc (Chemistry) having 23 yrs experience, Presently leading Quality Control Department and 3 USFDA Audits handled successfully at Auro Peptides Ltd [2016,2020(virtual),2024].Leading the QC team in internal/customer /regulatory audits with all time readiness and compliance. Organize the analysis and release of API/ Rawmaterials/Packing materials /Inprocess /intermediates /Cleaning, Microbiology (EM, BET, MLT). Method Validations,Method Equalencies, Method Transfers, Technology transfers. Expertise in CSV inline with GAMP5, EU Annexure 11, ICH Q7, Q9, Q12. Stability Management as per ICH conditions of all climatic Zones. GLP activities Reference standards, Working standards, Impurity standards, Primary standards qualification and management and instruments qualifications, Calibrations.Cleaning method validations according to APIC Guidelines. Management and investigation of QMS system i.e... Deviations, Change controls, OOS, OOT, OOCs, Incidents and recalls based on customer & regulatory complaints related to QC testing and procedures further assessment of impact on product quality and CAPAs implementation.Collaboration with other stakeholders like program management, Strategic Sourcing, Manufacturing, Engineering & Maintenance, EHS, Quality Assurance and Analytical Development to ensure successful project deliverables and business targets.Training on safety guidelines to team and monitoring of master equipment list, master calibration & Preventive maintenance schedules. Representation for Regulatory filings wherever required Prior Approval submissions, renewals/updates/supplements. Preparation of Capital and revenue budgets, manpower, resources projection requirement on yearly basis.Well experienced on risk assessment and limit fixation of Nitrosamine impurities, Genotoxic impurities and elemental impurities.Preparation, Review and approval of SOPs, Specifications, Stability Protocols, Method transfers, validation protocol, instruments qualification protocols and reports in line with current guidelines.Monitoring of CAPAs implementation, effectiveness for customer and regulatory audit observations and scheduled trainingsMotivational and periodical trainings to team for guidelines updating & on job trainings. Attending the daily/weekly Management Review meetings to understand and fulfill the business requirements then planned accordingly.Analytical R&D experience FD Studies, Method Developments, Absence Studies, Method equalencies (HPLC, GC, SEC, Aggregates, IC & Wet chemical methods).