Quality Manufacturing Engineer
shubham.singh@stefanini.com Open for W2 candidates only! 100% Onsite positionShift:
- Monday
- Friday 8:00am
- 5:00pm, 40 hours a week
-Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's).-Responsible for completing all training requirements and maintaining 100% compliance with all assignments.-Adapting Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, improve safety of the existing equipment, utilities, and facilities.
Coordinate activities with various departments and prepare technical reports.-Performing periodic reviews, statistical assessments, trend analysis and generate leading and lagging KPIs.-Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs).-Provide Technical assessments/ product impact assessment summaries on time.-Execute the trials and studies in coordination with planning, manufacturing, quality, engineering, and PM groups.-Review and analysis of the process, analytical and statistical data to support the qualification and validation work.
Analysis of data to ascertain the data meets protocol and product acceptance criteria: writes deviation reports and technical assessments as required.-Identify and coordinate the equipment requirements with R & D, Engineering, Employee Health, and Safety (EHS), and PM groups in preparation of Capital Expenditure Request (CER) for the commercial scale pre-validation development/ scale up of the ANDA lots.-Participation in internal (Corporate and QA audits) and external (FDA, MHRA) audits.-Remediation of the audit related observations (if any) and timely completion of the action items (if any).-Maintenance of appropriate documentation of protocols, reports and laboratory notebooks as required by Standard Operating Procedures (SOPs) and internal policies.-Lead process and equipment automation and modernization projects, creating automated trending and dashboards.-Actively participate in commercial pre-validation and provide technical support to the manufacturing and quality teams as required.-Leading multiple new technology introduction, upgrades, and automation.-Responsible for performing additional related duties as assigned.