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Quality and Regulatory Coordinator
Negotiable Salary
Indeed
Full-time
Onsite
No experience limit
No degree limit
Calle 94 Sur #50-51, Casa Jardin, Pueblo Viejo, La Estrella, Antioquia, Colombia
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Description

Quality and Regulatory Coordinator Apply Now Together Unstoppable! Company Overview **Connecting People Improving Lives** Become a DHL and get the essentials of your daily life, through the best benefits, we seek your safety, your health and that of your family. Build your career with us and have the opportunity to grow through multicultural experiences and challenges that will challenge you every day. This will not be just another job, it will be your opportunity to positively impact the environment and people both inside and outside DHL. As a global company, we value the diversity of our employees as a true strength, and this strength can only be leveraged if we make everyone feel they can truly be themselves every day, regardless of their ethnic origin, religion, sexual orientation, gender, disability or any other personal characteristic. That is what we mean when we talk about inclusion. **Diversity is our strength.** Being DHL means maximizing your capabilities. This position is for SUPPLA S.A description of the Role Oversee activities related to planning, implementation, monitoring and control of Good Manufacturing, Storage and Distribution Practices, as well as the Quality Management System in the secondary packaging area of the pharmaceutical sector, in order to comply with current regulatory requirements according to company guidelines and policies. Requirements Pharmaceutical Chemist, with extensive experience as technical director in companies in the pharmaceutical or cosmetic sector Responsibilities * Actively participate in the implementation and maintenance of the Quality Management System based on Good Practices (Manufacturing, Storage and Distribution) in operations within the regulated sector: Pharmaceutical * Ensure compliance with requirements from regulatory authorities in the regulated sector such as INVIMA, Health Secretariats, National Drug Fund, ICA, among others. * Coordinate and control activities related to product quality assurance and compliance with specifications established by clients and applicable current regulations for operations in the regulated sector. * Establish controls for compliance with regulatory requirements for each product handled in operations within the regulated sector. * Prepare and review written instructions and other documents, including modifications. * Monitor and control storage and secondary packaging operations for products regulated by health authorities. * Monitor and ensure proper hygiene conditions in storage and secondary packaging facilities for products regulated by health authorities. * Ensure and approve execution of equipment qualification processes, process and system validation, as well as calibration of measuring instruments. * Conduct training, including application and principles of quality assurance and GMP/GDP. * Audit, monitor and control critical GMP suppliers impacting product quality and/or services. * Monitor storage conditions of products and materials. * Ensure implementation, execution and monitoring of controls in storage and secondary packaging processes for products regulated by health authorities. * Retain records associated with GMP/GDP generated or held within the area. * Monitor compliance with GMP/GDP requirements. * Inspect, investigate and take samples to monitor factors that may affect product quality. * Approve or reject products and materials according to specifications provided by customers. * Ensure all necessary tests are performed for product approval and release of secondary packaging processes. * Approve sampling instructions, specifications, test methods and other product quality control procedures according to customer specifications JOB IDCO06557 COUNTRYColombia CITYLA ESTRELLA CATEGORYOperations

Source:  indeed View original post
Valentina Rodríguez
Indeed · HR

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