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- ...Administrative & according to business needs Bilingual: (Spanish and English) Experience in: Development and execution of protocols. CSV (Computer System Validation). Laboratory equipment. GMP environment and GDP regulations. The Personality Part:...SugeridoContratoTrabajo por turnos
- ...of GMP , FDA 21 CFR Part 11 , GAMP 5 , ISO 9001 , and data integrity principles. ~ Hands‑on experience writing validation protocols/reports (IQ, OQ, PQ) for lab/manufacturing systems. ~ Familiarity with risk assessment tools (FMEA), change control, CAPA, and audit...Sugerido
- ...certifications (e.g., Six Sigma, ASQ, CQE) is a plus. Technical Skills • Knowledge of validation methodologies (IQ, OQ, PQ) and protocols. • Familiarity with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and FDA/ISO regulatory requirements....SugeridoHorario flexible
- ...Qualification Execute Installation Qualification (IQ) , Operational Qualification (OQ) , and Performance Qualification (PQ) protocols for FTIR instrumentation. Develop, execute, and document validation protocols (Validation Plan, IQ/OQ/PQ, Final Report). Ensure...Sugerido