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Quality Operations and Services Professional
Negotiable Salary
Indeed
Full-time
Onsite
No experience limit
No degree limit
Isabel La Católica 5, Centro Histórico de la Cdad. de México, Centro, Cuauhtémoc, 06000 Ciudad de México, CDMX, Mexico
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Description

**The Position** --------------- Perform support activities for Quality Laboratory units to ensure proper operation of the various quality systems in place. Support digital systems, product life cycles, equipment, and planning within Quality areas, all in compliance with Safety, Hygiene, and Environmental Protection requirements, as well as Good Manufacturing Practices, as reflected in local and corporate guidelines and applicable national and international regulations. Lead digitalization and continuous improvement projects within Quality. **Tasks and Responsibilities** ------------------------------ * Conduct investigations of Out-of-Specification, Out-of-Trend, Out-of-Expectation results and discrepancies, identifying root causes and implementing corrective and preventive actions in accordance with applicable procedures and standards. * Coordinate execution of project-related tasks, such as process evaluations, process validations, and project stability studies. * Implement the Analytical Method Validation Master Plan, coordinate with the Validation Department, and verify compendial methods to ensure maintenance of validated status. * Support digitalization projects for new equipment and software. Ensure value generation in Quality area processes, in compliance with corporate guidelines and global and local regulations. * Participate in the development, updating, and review of procedures related to assigned activities. Support preparation for internal and external audits of the area. Coordinate laboratory equipment computerized systems. **Requirements:** -------------------- **Mandatory** --------------- * Professionals holding a degree and professional license in Chemistry, Pharmacy, or related fields. * Two to three years of experience in Quality Control and/or Quality Assurance areas. * Experience in pharmaceutical process validation for liquid and solid dosage forms. * Experience in documentation related to validation processes. * Project management and planning skills. * Intermediate to advanced level of English.

Source:  indeed View original post
Juan García
Indeed · HR

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