Biopharmaceutical industry-Design and manufacturing Fermentor , Process Vessel, Bioreactor, CIP & SIP System, etc. ASME U-STAMP approved company. Deals with pressure vessels from 5L to 10,000L. Supplied to different countries over the world includes India, Netherlands, Korea, South Africa, Iran, Israel, Cuba.
- Perform QMS implementation based on Quality control manual as per ISO 9001:2015 and ASME
- Review and verify Manufacturing Documents/Inspection Reports for projects and keep ready for FAT
- Develop and verify the ITP/QAP, validation plans and protocols, Weld plan along with Weld map, inspection methods, work instruction and inspection plans complying with project specification
- Develop and revise Quality Manuals, Procedures, SOPs, Checklists, GDP, NC reports, KPIs, etc
- Managed a team of engineers/technicians and providing guidance throughout the Quality cycle
- Collaborated with stakeholders to resolve technical issues & optimize processes for efficiency
- Executed IQ/OQ/PQ protocols for process equipment and ensuring systems met requirements
- Conduct, monitor and manufacturing investigation for OOS & OOT results and on-time closure
- Assuring quality parameters of the parts at supplier end as per agreed QAP/SOPs
- Review & evaluate supplier quality data to identify process improvement within supply chain
- Monitor, Verify and Control the incoming inspection, stage wise inspection as per quality plan & JBT
- Support Change control, appropriate impact assessment, approval, and on-time closure
- Welding In-charge- Monitor and control welding activities, Review and prepare welding documents WPS & PQR, Certify and Witness welder qualification, Continuity records and Weld Calculation
- Undertook R&D activities in welding to improve product quality and Defect & cost analysis
- Familiar to welding sections related to Standards ASME BPVC, PED, AD-2000Merkblatt
- Verify & assuring Final equipment with drawings, P&ID, SOPs, MBOM, Codes & URS before Pre-FAT
- Participate FATs activities with TPI/clients & meet within customer expectation & close MOM points
- Prepare, Analyze and Review the Departmental KPIs reports- NC in incoming inspection, Rejection rate reports, weld Defect analysis reports, Rework cost analysis, NC during FAT & SAT
- Prepare Control, monitor and timely closure of deviation and investigations to identify RCA and CAPA
- To Implemented risk-based approaches to qualification activities, reducing project timelines by 20%
- Monitor and execute improvements with help of Six Sigma, Kaizen, 5S, Lean, CAPA, 5M-1E & RCA
- Participated in cross-functional teams to troubleshoot equipment failures and implement CAPA
- Ensure avoiding rework and investigate for resolve quality issues and customer complaints
- Conducting periodical Internal audit and supplier audit, keep readiness for ASME and ISO audits
- Conducting Internal Audits, preparation of Audit reports and effective closure of all Audit findings
- Ensure planned tasks are delivered on time, cost saving initiatives and on the quality of performance
- Identify the area of improvements for training requirements and conduct training to team members.