Sudesh Kumar Sahu Email & Phone Number

Gurugram, Hr, In

Gurgaon, Haryana

Baddi

• • Ensure Site Quality compliance thru effective QMS, Company Internal Standards & ISO requirements.• Ensure GMP & Regulatory compliance of the site as per local regulations & WHO GMP.• Accountable for Lab capability as per GLP and Regional laboratory requirement .• As a Management ,Responsible for carrying out hiring & training, employees; planning for work allocation between team ,Goal setting and performance review and addressing team members business concern and problems• Responsible for Product releases as per Norms & Material quality by ensuring robust control on Suppliers.• Ensure Quality department readiness for all Internal & External audits and Compliances.• Responsible for ensuring controls and standards implementation in Quality for Validations, Calibrations, PM, Quality system (CAPA ,NC,IA and Document & records managements.)• Site Training Compliance, Talent development & Building Resource pipeline thru Training needs identification & Backup Matrix.• Ensure Budget (CAPEX & OPEX), Quality Metrices & Safety standards are maintained and in favorable state.• Responsible for reporting timely and accurate metrices as per J&J requirements.• Ensure CIP & Validation projects completed on time.• As a Site Management Representative ensure QMS is effective, CAPA implemented for recurring problems and system improved continuously. • As a Site PLT member, Ensure management initiatives like Kaizen, Rewards and Recognitions and GEMBA walks executed to improve team engagement & commitment to meet Plant Goals & objectives.

• Ensure daily management system of QA lab for IVC (intravenous catheter) & Syringes as per GLP and company standards.• Responsible for Batch releases from Unit quality (Sweden) in stipulated time.• Owning CAPA system for Plant and ensure CAPA effectiveness to prevent problems to reoccur by applying RCA methodology.• Owning customer complaint Management by ensuring proper Root cause & implement CAPA for the same. • Owning Audit managements for the plant & suppliers.• Ensure Trainings on QMS,GDP,GLP to line Associate & new hires induction including Marketing Induction of Quality.• Lab Management by Managing a team of 15 lab associates , implementation of GLP requirements ,lab budget & COQ(Cost of Quality) for Plant .• Ensuring quality system for the plant as per GMP requirements .(Ensure all documentation ,change controls and process improvements as per corporate & local procedures).• Ensuring Supplier Quality by performing Audits as per schedule calendar.• Driving CI initiatives for Quality lab by ensuring Kaizen implementation• Ensure all quality metrices reported on time to management & worldwide quality team.• Team members for driving safety culture in plant ,employee engagement initiatives & social responsibility initiatives.• Responsible for meeting the compliance of ISO 14001, ISO 9001 & ISO 13485 requirements as integrated management system in lab & operations .

I was in Quality assurance at Baddi Plant Plant from 2006-2010.

I was QA officer at Kasna Plant .Handled QC,QA activities

Master'S Degree, Chemistry, First Grade

M.Sc, Chemistry

Bsc, Bsc

Activities and Societies: project in college completed

Master Of Science - Ms, Chemistry