for registered products.- Coordinate product renewals on due date.- Request and organize all GMP Inspections at international...
Participate in the Validation of Processes and/or Raw Material. (QS 9000 AND GMP's (Good Manufacturing Practices)- QSR's -Quality...
and subcontractors.- Develop and maintain an effective Pharmaceutical Quality Management System (QMS) to align with EU GMP, GDP, GVP... organizations.- Develop and maintain a comprehensive understanding of EU GMP and GDP regulatory requirements.- Manage key quality...
or other regulated industry is required. Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485...
of the quality system to meet with ISO 13485:2016of the Quality System Regulation (QSR)/Good Manufacturing Practices (GMP...
practices (GMP) and quality standards are met.- Evaluates suppliers' internal functions to assess their overall performance...
with special regard to ISO, EN4600 and GMP documentation.- Monitor departmental activities and provide technical and logÃstical...
and preventive actions, and compliance to Quality System Regulation (GMP), and ISO 13485...
assure compliance to in-house and/or external specifications and standards (i.E. GLP, GMP, ISO, Six Sigma). **Your Toolkit...
of compliance management, GMP/GLP principles, and cGMPs. Familiarity with Quality Systems (including EQV, Change Controls...