que las actividades asociadas a la Calidad llevadas a cabo en el ámbito del IPT Producción Biológicos Inactivado cumplen la normativa GMP... Compliance, cGMP Regulations, Data Analysis, Decision Making, Documentation Review, Documentations, FDA Regulations, GMP...
with current regulations (including but not limited to: GMP, GDP and ICH Quality guidelines) to guarantee that medicinal products... and customers. Prepare and execute GMP training. Attend requests regarding quality related to marketed products. Participate...
en la elaboración y revisión y/o elaborar los procedimientos GMP del área conforme a los estándares que son nuestra responsabilidad...
, 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...