Shivbachan Singh Kushwaha
Quality Assurance Manager @Johnson & Johnson
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WORK HISTORY
Quality Assurance Manager @Johnson & Johnson
Aurangabad, IN
Spearheading efforts as a QA Manger for Aurangabad Site and accountable for oversight and execution of Quality Management Systems at Aurangabad site that manufacture sutures and delivers finished goods to distribution centers.\\\\n•Planning, coordinating, and directing quality assurance programs designed to ensure effective and consistent processes with established standards by performing the duties personally or through subordinates\\\\n•Accountable for handling Special Processes like QA controlled document issuance, batch Card Review and Batch release authorization and also Stability study program.\\\\n•Handling the product Complaint Management Process. Responsible for overseeing the controls and quality standards for Quality systems validation, including, Cal/PM, CAPA, NC, IA, Doc mgmt. software systems\\\\n•Responsible for ensuring the quality of incoming raw and packaging materials, process control activities, specially to minimize deviations thereby helping to reduce material usage variances\\\\n•Responsible for assurance of supplies through supplier audits and feedbacks\\\\n•Aligned QA function vision with the Company goals, leading the team for achieving the objectives and built alliance to support other functions and overall business\\\\n•Accountable for management of Quality systems, document management, change control and record management.\\\\n•Accountable for review and approval of quality documents in document management system.\\\\n•Responsible and accountable for Quality Operations department yearly business planning, capital, quality system and product process projects.\\\\n•Responsible for regulatory submissions, managing relationships within the relevant regulatory agencies;\\\\n•Carrying out managerial responsibilities in accordance with the organization\'s policies and applicable laws; including, interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; addressing complaints; and, resolving problems.\\\\n\\\\n
EDUCATION
ICFAI University
Master of Business Administration - MBA, Operations Management
University of Mumbai
B.Sc, Microbiology
Indian Institute of Technology, Kharagpur
M.Tech, Biotechnology
University of Mumbai
M.Sc., MicrobioIology
ICFAI University
Master of Business Administration - MBA, Operation Management
Institute of pharmaceutical education and research, Pune
Diploma in Pharmaceutical Quality control & Quality Assurance Management, Quality Control Technology and Quality Assurance
ICFAI University
Master of Business Administration - MBA, Operation Mananagement
ABOUT SHIVBACHAN SINGH KUSHWAHA
An Accomplished Professional with incredible experience acquired over 30+ years in diverse areas encompassing Research & Development, Operations Management including greenhouse Operations, Quality Audits, Quality Systems Implementation, Reporting & Documentation, Regulatory Compliance, General Management. Proactive professional with proven ability to streamline production, quality assurance, research & development, new product development functions to optimize operational efficiency. Strong background in judiciously deploying plant resources - Manpower, Materials and Machines to maximize capacity utilization and achieve profitability milestones. Fully conversant with Statutory & Regulatory requirements for uninterrupted site operation and Product Quality Standards. Deft in leading mass movements involving hundreds of direct and indirect employees to significantly enhance Quality Standards of products, supply chain and distribution. Demonstrated strengths in implementing and improving Quality standards and norms. Proficient in modern manufacturing management and quality systems such as HACCP, TPM, ISO, etc. Expertise in conducting Quality Audits and evaluating internal control systems to ensure adherence to stringent quality standards; identify shortcomings and recommend need based solutions. Seasoned professional, with planning, implementation, monitoring and resource balancing skills and ability to handle multiple functions in high pressure environments. Suave and pragmatic with excellent interpersonal and communication skills, competent to work in highly diverse environments with people from varied backgrounds. Keen planner and farsighted with strengths to perceive beyond obvious. Result driven and focused with immaculate work habits, excellent man-management, time management and leadership skills
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