Nikunj Patel
Quality Assurance Manager @ Lonza
- Role
- Quality Assurance Manager at Lonza
- Location
- Richmond, TX, US
- LinkedIn followers
- 500 followers
About Nikunj Patel
Dedicated Quality Assurance Manager with comprehensive expertise in all facets of QA operations, laboratorymanagement, and adherence to policies and procedures. Proven track record in hiring and nurturing individual team members to cultivate a high-performing workforce. Committed to conducting meticulous assessments of product quality and manufacturing processes, driven by a robust engineering background. Recognized as aCertified FMEA specialist by AIGPE/CPD and LBMS Yellow Belt certified, with additional proficiencydemonstrated through Lonza Qualified Train the Trainer program. Passionate about achieving excellence andensuring customer satisfaction through stringent quality standards.
Experience
Quality Assurance Manager
Aug 2022 — Present · Houston, TX, US
Led root-cause investigations, CAPAs, and change controls using risk-based tools such as FMEA and RCAto support continuous improvement.Reviewed and approved master specifications, sampling plans, test methods, master and executed batchrecords, and analytical/biological test data to support batch disposition.Provided QA oversight for qualification and validation programs, including facility, utility, equipment,cleaning, process, and aseptic validation activities.Managed QA operations including batch release, on-the-floor QA support, MODA data review, andoversight of APS activities, reducing batch release timelines by 50% through automation.Supported sterile and aseptic clinical and commercial manufacturing by leading readiness activities acrosstraining, documentation, validation, and system qualification.Maintained site quality systems for manufacturing and QC, including document control, auditmanagement, and ongoing regulatory compliance.Built operational quality dashboards, tracked KPIs and risks, and mentored QA teams to improve siteperformance and quality culture.Led inspection readiness efforts and successfully supported FDA, EMA, MHRA, DEA, JP, and clientinspections with no critical observations.Developed and coached QA teams through structured training and continuous professional development.
Education
G H Patel College of Engineering & Technology
Bachelor's degree
2004 — 2008
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