, mantenimiento). Asegurar el cumplimiento de normativas GMP, GAMP5 y estándares de validación aplicables al sector farmacéutico...). Familiaridad con normativas GMP, FDA, GAMP5 y documentación de validación. Capacidad de planificación, gestión y liderazgo...
y proveer soluciones que cubran dichos requerimientos. Supervisión del cumplimiento de regulaciones GMP en el ámbito SAP... de regulaciones del sector farmacéutico, especialmente de las buenas prácticas en la fabricación (GMP). Se valorará contar...
, and computerized systems. This role ensures compliance with GMP standards, regulatory requirements, and internal quality policies.... Experience with sterile dosage forms Proven experience with Eudralex Annex 1 regulation is mandatory. Strong knowledge of GMP...
, EMA, Health Canada, MHRA, PMDA, among others) and with corporate policies and standards (EU GMP, 21 CFR, ICH Q10, ISO 9001...
such as JMP, SIMCA, MODDE Excellent understanding of processes associated with CMC, GMP quality concepts (including ObD) used...
industry. Its laboratories are GMP and GLP certified and GCP compliant, and have been successfully inspected by EMA, FDA... of biological products in a GMP-regulated environment. Key responsibilities: Design, execution, and oversee of analytical method...
skills You bring knowledge of legal, regulatory, and GMP compliance requirements in the pharmaceutical environment...
with applicable regulatory standards (e.g., FDA, GMP, GxP guidelines) and partner with stakeholders in IT and Internal Control...
pharmaceutical and biotech companies. Our facility at Larrabetzu (Biscay, Spain) offers state-of-the-art development and GMP..., regulatory requirements and GMP manufacturing is highly regarded). Skills & Competencies: Excellent communication skills...
and sustainability practices. Proven experience working in GMP environments. Advanced proficiency in spoken, written, and understood...