Capa Resumes

San Antonio, TX
... Working across multiple departments, I supported CAPA investigations and maintained audit readiness for internal, client, and third-party inspections. Much of this work was performed in a remote capacity, requiring accuracy in documentation review ... - 2025 Dec 02

San Diego, CA
... Consulting Projects: 2018 – 2022 oFujifilm Diosynth Biotechnology oFive Prime Therapeutics/Amgen oGlobal Blood Therapeutics oBeigene Pharmaceutical oMyovant Pharmaceutical Provides Quality (QMS) PM Oversight/Governance – Risk Assessments, CAPA ... - 2025 Dec 02

Pune, Maharashtra, India
... Problem solving & Analysis: RCA,5Why,Fish-bone Diagram, CAPA,SPC,MSA,CP,CPK,7QC,3M. Testing Knowledge: Mechanical testing, Chemical testing,impact testing,Proof load, Mill TC,tensile testing. Software Skill: Ms Office, Excel, Power Point, ERP,QI ... - 2025 Nov 30

Salmiya, Hawalli, Kuwait
... Monitor the implementation of corrective and preventive actions (CAPA) from previous inspections or incidents. Conduct regular site inspections to identify unsafe acts, unsafe conditions, and non- compliance with safety standards. Ensure compliance ... - 2025 Nov 29

Middletown, DE
... CORE COMPETENCIES Computerized System Validation (CSV), CAPA / Quality Systems, Data Integrity & Compliance (ALCOA+), USP <1058> AIQ, USP/EP/JP/ICH, Risk Assessment / Gap Analysis, Product & Service Marketing, FDA / ISO Regulatory Compliance, NPI ... - 2025 Nov 29

Pune, Maharashtra, India
... Demonstrated expertise in ISO 9001, IATF 16949, and core quality tools including APQP, PPAP, PFMEA, MSA, SPC, and CAPA, with a proven record of driving defect reduction and operational excellence through Lean Six Sigma methodologies. Strong ... - 2025 Nov 28

West Roxbury, MA
... SKILLS Regulatory & Quality Systems: FDA 510(k), PMA, IND/NDA/BLA/ANDA, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, ICH Guidelines, Clinical Trial Regulation, PMS, CAPA, Root Cause Analysis, QSR Audits, Global Policy Monitoring (FDA, EMA, PMDA, APAC, ... - 2025 Nov 24

Illinois
... attempt PPAP, APQP, FPA acceptance record Support Sigma Tron Medical device division located union city in internal and external CAPA as team leader -involves root cause analysis, action plan to prevent defects Worked on permanent 8-D preventative ... - 2025 Nov 24

Anaheim, CA
... Time to Work divided by Customer Demands will give piece work time (min/piece) Setup of Lab Equipment periodic reviews including calibration and specifications updates Investigated equipment for a Process Deviation and generated CAPA reports. ... - 2025 Nov 24

Tabuk, Saudi Arabia
... Proven track record of delivering quality excellence, improving Project Quality Index (PQI) to 90%+, embedding risk-based methodologies (FMEA, RCA, CAPA), and leading organization-wide quality transformation initiatives. Skilled in multidisciplinary ... - 2025 Nov 22