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

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

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

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, ICH-GCP E6 R2 R3, Data governance frameworks

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

trackwise , Jmp, Analytical QA, Hplc, Quality Systems, Bioanalytical test methods, cGMP regulations, eDocument Management, Risk management, Risk Assessment, laboratory practices, Minital, training systems

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

Regulatory Services, Operational Audit Compliance, Quality Governance Services, Clinical Pharmacovigilance