Microsoft Office, Compliance, Lean Principles, Audit, Six Sigma, Risk Management

Erp, Spi, AOI, Iso 13485, IPC standards, Fmea, PCBA Process Quality Assurance, IATF 16949, 8D, Dfm, Capa, Lean Six Sigma, quality reporting systems, Dft, Iso 9001, Fishbone, FCT, Ict, As9100, Mes

Iso 9001, Iso 14001, ISO 45001, risk-based auditing, quality management systems, audit principles

Sap Ecc, cost of quality, gap assessments, operating procedures, Investigations, Problem Solving, Root Cause Analysis, Operational Risk Management Framework, Capa, analytical metrics, Mdg, Product Master data management, trending quality planning, SOX Controls, regulations, Quality Systems, MDM, Statistics, Validation, corrective actions

metrics reporting , Quality Assurance Engineering, AI ML-driven product quality programs, test automation frameworks, quality assurance team management, Lean Process Improvement, Production Monitoring, Six Sigma methodologies

FDA regulations e.g. 21 CFR Part 11, Data review expertise across computerized systems including LIMS, Data governance frameworks, GxP frameworks GCP GMP GLP GCLP, Understanding of Audit trails metadata and system validation, EMA EU CTR Annex 11, ICH-GCP E6 R2 R3

FDA regulations e.g. 21 CFR Part 11, EMA EU CTR Annex 11, GxP frameworks GCP GMP GLP GCLP, Data review expertise across computerized systems including LIMS, Understanding of Audit trails metadata and system validation, Data governance frameworks, ICH-GCP E6 R2 R3

Data Security, Operational Audit Compliance, Quality Governance Operations, Quality Management Plan, Clinical Pharmacovigilance, Document Management

IATF 16949, Lean Six Sigma, Iso 9001, Capa, Gmp, Fmea, Spc, Tpm, 5S, Oee

Quality Assurance, Verification, 21 CFR Part 820, Design controls, IEC 62304, EU MDR, Iso 13485, Risk management, Capa, Iso 14971, Change deployment, Validation, IMDR, Qms, Systems engineering