Browse
···
Log in / Register
Job Summary: A Quality Assurance professional to collaborate on document management, procedure development, audits, and product management, ensuring compliance and quality. Key Highlights: 1. Collaborate in the management of Good Practices documentation 2. Develop and review Quality Assurance procedures 3. Assist in regulatory audits and product inspections Description: * Bachelor's degree completed, preferably in Pharmacy, health-related fields, and/or the pharmaceutical industry. * Intermediate English; * Proficiency in Microsoft Office suite * Good Manufacturing Practices (GMP) * Good Laboratory Practices (GLP) * Good Storage and Distribution Practices * Basic knowledge of transportation validation * Collaborate in managing documentation related to Good Practices—including Quality Policies, Standard Operating Procedures, technical report coding, and training programs—with the objective of maintaining documentation traceability and providing support to analysts. * Develop internal procedures/documents related to Quality Assurance and review procedures/documents related to compliance with Good Practices, aiming to meet current legislation. * Assist in completing the Out-of-Specification (OOS) laboratory investigation record to meet standards required by regulatory authorities. * Assist in managing product specifications, analytical methods, and validation documentation, aiming to provide up-to-date documentation to partner departments. * Prepare, maintain, control, and distribute Logbooks (Registration Books) for partner departments, aiming to provide current and controlled documentation to partner departments. * Assist in external regulatory audits to maintain active Good Practices licenses. * Assist in inspections of products received from the parent company when quality deviations are suspected, to ensure products meet quality standards. * Review batch release documentation to ensure compliance with current regulations and product quality in the market. * Evaluate market return documentation to ensure compliance with current regulations and product quality. * Monitor and evaluate the supervisory system for environmental condition monitoring of products. * Prepare quality performance indicator data and conduct trend analyses to maintain an effective quality system. * Conduct training sessions to ensure necessary instructions are provided for activity execution. * Evaluate, monitor trends, investigate, and propose improvement actions regarding market complaints, aiming to improve processes and comply with current legislation. * Perform sampling and sample shipment 2512250202491523462
