Shukoor A.
Sr. Quality Assurance/Process Analyst at Novo Nordisk
- Role
- Senior Qa Analyst at Novo Nordisk
- Location
- Bloomington, IN, US
- LinkedIn followers
- 500 followers
About Shukoor A.
Mechanical Engineering Professional possessing excellent knowledge & problem solving…
Experience
Senior Qa Analyst
Dec 2024 — Present · Bloomington, IN, US
Initiating Quality Records and conducting deviation investigations that meet both Industry and Catalent expectations. Perform manual audits and resolve outliers/exceptions. • Leading and managing investigations, including root cause analysis, and assessing product impact using input from various departments. Update quality documentation and communicate lessons learned from quality concerns. • Developing, executing, and overseeing Corrective and Preventive Action Plans (CAPAs). Do root-cause analyses within the space and contribute to write correction of error (COE). • Providing technical leadership to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.• Supporting Tech transfer and process monitoring support as needed.• Working with the team to monitor critical process parameters and implementing corrective actions to improve product quality and efficiency.• Coordinate in revising and managing manufacturing documents such as Batch Records and SOPs.• Leading or supporting Continuous Improvement projects to optimize process efficiencies and reduce waste.• Conducting data gathering, trending, and data presentation as needed to support investigations.• Being responsible for real-time, on the floor response in support of operational deviations by gathering information and completing an initial event report.
Education
Osmania University
Engineer's Degree, Mechanical Engineering
2010 — 2014
Campbellsville University
Master of Business Administration - MBA, Information Technology
Bradley University
Master of Science (M.S.), Mechanical Engineering
2014 — 2016
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