Capa Resumes

Massachusetts
... Well versed with FDA 21CFR 820, ISO 13485:2016, ISO 14971:2019, 2017/745, QMSR, CQA, GAMP5, and IEC 62304, CAPA, NCMR, MDD, MDR. Conducted validation and Verification Testing reviews during Product development process. Performed Test Plan/Test case ... - Mar 13

Dubai, United Arab Emirates
... Identify non-conformities, issue NCRs, and support Corrective & Preventive Actions (CAPA). Review technical drawings, BOMs, and inspection test plans (ITPs). Maintain quality documentation: inspection reports, test records, and compliance logs. ... - Mar 11

Warsaw, IN
... NPI, Validation (IQ/OQ/PQ) Quality & Continuous Improvement: Lean Six Sigma Green Belt, DMAIC, RCA, SPC, Gage R&R / MSA, CAPA, 8D Problem Solving, Kaizen, 5S, ISO 9001 / ISO 14001, FDA 21 CFR, ISO 13485 Design & Data Tools: SolidWorks, Creo, CATIA ... - Mar 11

Irving, TX
... ●Supported CAPA activities and maintained traceability matrices using Jira and Windchill. ●Participated in Agile ceremonies including sprint planning, daily stand-ups, retrospectives, and release readiness reviews. ●Performed UAT testing with ... - Mar 11

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 09

Sharon, MA
... Adept at leading quality audits, managing CAPA and NCR processes, and driving continuous improvement initiatives. Strong leadership and communication skills with a focus on fostering collaborative and compliant work environments. Key Skills • ... - Mar 08

Clifton, NJ
... Head of R&D Quality, Tonix Pharmaceuticals 2021 – 2022 Established R&D Quality including implementation of QMS, auditing and CAPA Programs Oversight of R&D Quality for process improvements including training and regulatory compliance Developed and ... - Mar 06

San Diego, CA
... Over the years, I have developed special skills that would allow me to work with and manage internal customers as well as External customers (in working and/or developing method for generating CaPA, SCAR & 8D reports). Managing suppliers’ quality ... - Mar 05

Bloomfield, NJ, 07003
... Clinical Data Entry Associate Support R&D QA & PV to manage and maintain Track Wise workflow data Monitor mailbox of NCR’s and CAPA information, Enter into internal database Responsible for verification and update on Excel spreadsheets Manage Triage ... - Mar 04

Montreal, QC, Canada
... des rapports de coûts et rendement des opérations et de l'écart de rendement des opérations, et les plans d'action pour les CAPA - Géré les budgets des opérations, de fabrication, d’entretien préventif et de projets capitaux d'usine - Fait l'analyse ... - Mar 03