Capa Resumes

Parsippany, NJ, 07054
... •Expertise for CAPA and non confirmance and prepared documented evidence for regulatory audits. Bristol-Myers Squibb,Summit West,NJ May 2019 to Jan 2024 Senior QA/Regulatory Affairs Compliance •Preparing and submitting regulatory filings, including ... - Mar 27

Northbrook, IL
... CORE QUALIFICATIONS • GMP / GLP laboratory operations, FDA compliance (5 years) • HPLC, GC, UV-Vis, dissolution • Data integrity ALCOA+ • Laboratory investigations (OOS, CAPA, deviations) • Sample preparation & analytical testing • Result review and ... - Mar 27

San Antonio, TX
... At Phoenix Clinical Research, I advanced from CRC to CRA and Clinical QA Lead, directly executing SDV/SDR, risk-based monitoring, and CAPA programs - skills directly applicable to the supervisory and compliance responsibilities this role demands. My ... - Mar 27

Orlando, FL, 32801
... FMEA, ISO 14971, hazard analysis, risk controls Regulatory & Quality: 21 CFR Part 820, ISO 13485, EMA 2001/83/EC, GMP, GLP, GDP, CAPA, assisted with regulatory submissions Software: SolidWorks (Coursera), Excel, GraphPad Prism, COMSOL, Salesforce ... - Mar 25

Chennai, Tamil Nadu, India
... Managed difficult IR situations Anchored 5s, TPM, My machine concepts to ensure good hygiene is maintained in the floor Key role in developing safety systems like, permit, CAPA, LOTO etc. Improved the awareness on various KPI’s of the plant through ... - Mar 24

Mumbai, Maharashtra, India
... Client Relations: Proactive client communication, handling client queries, and providing RCA and CAPA. Regulatory Knowledge & Compliance: Good understanding of applicable global, regional, and local PV regulatory requirements with ensuring ... - Mar 24

Twin Lakes, WI
... a.Supported internal/external quality audits b.Identified and documented deviations and non conformance to SOPs c.Determined CAPA and monitored results ● Systems used: SAP, iREP, Kiteworks, Clarify, Javlin, Microsoft Office Suite (Excel, Word, ... - Mar 23

Oakville, ON, Canada
... FAI) ● Root Cause Analysis (5-Why, Fishbone) ● Cost of Poor Quality (COPQ) ● HACCP, GMP ● Corrective and Preventive Actions (CAPA) ● Gage R&R and Calibration ● Time Studies (Most, MTM) ● Work Standardization ● Problem Solving (8- D) ● Cost and Waste ... - Mar 22

Lombard, IL
... ● Identified system and process failures, implemented and maintained CAPA documentation, and streamlined workflows through Value Stream Mapping and team training to sustain continuous improvement. ● Developed Arena simulations for inventory and ... - Mar 22

Hyderabad, Telangana, India
... Conducted daily reviews of IT tickets, projects, QMS deviations, change controls, CAPA effectiveness, investigations, audit observations, qualification documents, and periodic reports. Digitally signed, reviewed, and approved GxP/non-GxP documents; ... - Mar 21