Description
Job Summary:
Lead the planning, implementation, and control of Good Practices and the Quality Management System in pharmaceutical secondary packaging.
Key Highlights:
1. Build your career with us and grow through multicultural experiences.
2. Positively impact the environment and people.
3. Maximize your capabilities in an inclusive environment.
**Company Overview**
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**Connecting People, Improving Lives**
Become a DHL professional and secure the essentials of your daily life through our best benefits—we prioritize your safety, health, and that of your family.
Build your career with us and seize the opportunity to grow through multicultural experiences and daily challenges that will push you further.
This will not be just another job—it will be your chance to make a positive impact on the environment and on people both within and outside DHL.
As a global company, we value the diversity of our employees as a true strength—and this strength can only be fully leveraged if everyone feels they can truly be themselves every day, regardless of ethnic origin, religion, sexual orientation, gender, disability, or any other personal characteristic.
That is what we mean by inclusion.
**Diversity Is Our Strength.**
Being DHL means maximizing your capabilities.
This position is for SUPPLA S.A.
**Role Description**
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Oversee activities related to the planning, implementation, monitoring, and control of Good Manufacturing, Storage, and Distribution Practices, as well as the Quality Management System for the pharmaceutical secondary packaging area, to ensure compliance with current regulatory requirements according to company guidelines and policies.
**Requirements**
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* Graduate professional in Pharmaceutical Chemistry.
* Minimum 3 years of experience in implementing and maintaining quality management systems, Good Manufacturing Practices, storage and distribution practices in the pharmaceutical industry, secondary packaging, personal care, cleaning and hygiene, and medical devices and diagnostics. Process release for secondary packaging; experience in implementing and maintaining quality systems, internal and external audits, release of production processes, and responses to and investigations of customer complaints, inquiries, and suggestions (PQRs).
**Responsibilities**
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* Actively participate in the implementation and maintenance of the Quality Management System based on Good Practices (Manufacturing, Storage, and Distribution) in regulated-sector operations: Pharmaceutical.
* Ensure compliance with regulatory requirements from regulated-sector authorities such as INVIMA, Health Secretariats, National Narcotics Fund, ICA, among others.
* Coordinate and control activities related to product Quality Assurance and compliance with specifications established by customers and applicable current regulations governing regulated-sector operations.
* Establish controls to meet the regulatory requirements for each product handled in regulated-sector operations.
* Draft 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 control the proper hygienic condition of storage and secondary packaging facilities for products regulated by health authorities.
* Ensure and approve the execution of equipment qualification processes, process and system validation, as well as calibration of measuring instruments.
* Deliver training, including application and principles of quality assurance and GMP/GDP.
* Audit, monitor, and control critical GMP suppliers whose performance impacts product and/or service quality.
* Monitor storage conditions for products and materials.
* Ensure implementation, execution, and monitoring of controls in storage and secondary packaging processes for products regulated by health authorities.
* Among others.