Satish Kumar V Email & Phone Number

Karnataka, India

Karnataka, India

Bengaluru, Karnataka, India

Handling QMS activities includes Deviation Investigations, Change control and CAPA management. Implemented lean concepts in day to day activities which benefited the organisation and people performing the duties. Improvement in Quality KPIs by adopting lag and lead KPIs concepts.Audit management - perform Internal audits and providing response to the external audits.Review and approval of SOPs and QMS documents like SMF, VMP and Quality policy.Drive Monthly Quality performance meetings as part of continuous improvement. Timely Escalation of unsolved issues to higher management.Skilled in Track Wise application implementation. Resolving day to day issues from users. Escalation to Vendor for any unresolved issues and get it solved in a timely manner without impacting day to day activities.Skilled in end to end Market complaint management.Handling of Site Quality Risk Management.Handling Vendor issues/Complaints. Assess Investigations from vendors for appropriateness before implementation.

Bangalore Urban, Karnataka, India

Handling Supplier Quality Management, asses vendor notification in compliance to Regulatory requirements, Change control management for supplier changes, Vendor complaint management CAPA and Trackwise management, Handling Supplier issues and ensuring compliance to Regulatory/Customer queries.Co-ordinate with suppliers for any Regulatory queries w.r.t filings and ensuring compliance.

Bengaluru Rural, Karnataka, India

Site QMS Champion, Implementation of QMS at brand new facility. Acted as Site Implementation Manager and deployed Trackwise successfully. Certified Internal Auditor to perform Audits. Assessment of Quality Alerts. Successfully received Manufacturing license and cleared Global GMP Audit. Assessment and approval of Change controls, Deviations and CAPA.Implemented Quality Dashboard for KPIs at new facility. Initiated Quality Improvement Plans to achieve Zero defects and Zero errors.Certified Trainer the Trainer for conducting GMP Trainings.Trackwise Superuser at Site, Conducting Trainings on Trackwise for new users based on role, provide access for new users, trouble shooting of issues raised on Trackwise from various functions on day-to-day basis. Attend monthly Superuser forums for continuous improvement.Organize for monthly Site Quality Council meetings, discuss outstanding issues and escalate any unresolved issues to Regional Quality Council.Implementation of QMS SOPs at site in compliance to Global Quality Policies and local Regulatory requirementsProvide response to Audit observations and ensure compliance to the Regulatory requirements.

Bengaluru, Karnataka, India

Handled Quality Management- CAPA, Change control assessment and approval, Deviations assessment and approval, lead Investigations.Compilation of Canada APQRs, Perform Hold time studies for Oral solids, Assess Quality Investigations, Preparation of Process Validation protocols and reports for regulated markets, follow up with stakeholders for effective closure of Deviations, CAPA and Change controls, performing internal audits, preparation of SOPs.Trackwise Superuser at Site, Conducting Trainings on Trackwise for new users based on role, provide access for new users, trouble shooting of issues raised on Trackwise from various functions on day-to-day basis. Attend monthly Superuser forums for continuous improvement.Participated in 4 USFDA, 2MHRA, 3 Health Canada and 2 TGA audits during the tenure.

Bangalore

IPQA activities for Semi solids, Oral liquids, External drops, Shampoos, Opthalmic ointments and Antibiotic Powder. Management of QMS, Preparation of Quality Manual, Site Master Plan, Validation Master Plan, AHU validations, Handling of Market compliant, Cleaning validation, Process Validation, APQR compilation, Internal audits, Audit compliance, monthly reports, performing Annual review of all Quality elements and initiating improvement actions, Qualifications of Utility Systems including AHU, Compressed air and water systems in new liquid facility

Bengaluru, Karnataka, India

IPQA activities in Tablets and Capsules, SOPs preparation, BMR and BPR review, Process Validation and Cleaning validation, Site Master Plan, Validation Master Plan

Master Of Technology - Mtech, Quality Management

B.Pharm.