industry is required.- Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO...
with special regard to ISO, EN4600 and GMP documentation.- Monitor departmental activities and provide technical and logÃstical...
(GLP) and Good Manufacturing Practices (GMP).- Stay updated with the latest advancements in digital quality control systems... Practices (GMP).- Proficiency in configuring and customizing Labware (GLIMS) workflows and functionalities to meet specific lab...
meet established quality standards.- Implement and maintain the Quality Management System (QMS) in accordance with GMP...
certifying and regulatory audits (ISO / FDA). Extensive knowledge on GMP's. English 80 % Proactive, analitycal, outspoken...
position. Written and spoken English required. Knowledge of requirements of FDA QSR's GMP's and ISO 13485 or similar...
situations. Essential Skills/Experience Degree in a scientific subject area with 8-10 years of experience in a GMP (Good... Manufacturing Practice) environment. In-depth knowledge of compliance management, GMP/GLP principles, and cGMPs. Familiarity...
/ Spanish required. GMP/ ISO knowledge preferred. Knowledge of Mexican Labor Law. Proficient in Communication Skills: Oral...
Quality System and GMP/ISO standards. Completion of risk management and risk analysis including FMEA. Also, provide... or leading multi-departmental project teams. Quality auditor Detailed knowledge of FDA, GMP, and ISO 13485 or Lead Auditor...
, etc.) and audits (External / Internal). Main Responsibilities Verify company´s adherence to the established Quality System and GMP... working on FDA, GMP, and ISO 13485 Regulated environments. Experience in process improvement tools such as: Root Cause...