Technical Directorate Cacém

Description

Job Summary: The plural\\+udifar is seeking a Technical Director to ensure quality, safety, and technical integrity of pharmaceutical operations and regulatory compliance. Key Highlights: 1. Ensure technical and regulatory compliance in pharmaceutical distribution. 2. Promote continuous improvement of the Quality Management System. 3. Represent the company before regulatory and sectoral authorities. The **plural\+udifar**, a reference in the pharmaceutical distribution sector, seeks a Technical Director who wishes to assume a central role in ensuring quality, safety, and technical integrity of an evolving pharmaceutical operation. **Location:** Cacém Platform \- Lisbon **Mission:** Ensure technical and regulatory compliance of pharmaceutical distribution activities, guaranteeing adherence to Good Distribution Practices (GDP), as well as product quality and safety and the effectiveness of the Quality Management System, promoting continuous operational improvement. Also responsible for the regulatory framework and compliance of private-label services and products, ensuring coordination with regulatory bodies. **Responsibilities:** * Ensure compliance with Good Pharmaceutical Distribution Practices, Technical Directorate directives, and applicable regulations from INFARMED, DGAV, and other regulatory authorities, guaranteeing legal and technical compliance of all operations. * Support implementation, maintenance, and continuous improvement of the Quality Management System (QMS), promoting effectiveness of technical and operational processes and alignment with applicable regulations. * Ensure the company’s regulatory compliance by monitoring legislative developments and market best practices, coordinating with operational and commercial departments, and guaranteeing regulatory compliance, quality, and safety of marketed products—including private-label items and medical devices. * Coordinate and monitor environmental parameters across the entire distribution chain, ensuring maintenance of regulatory limits defined in Good Distribution Practices. * Supervise timely product recalls, ensuring effective communication with customers, suppliers, and competent authorities. * Manage technical complaints, ensuring investigation, root cause analysis, and implementation of corrective and preventive actions. * Represent the company institutionally before regulatory and sectoral authorities, ensuring effective technical communication and defense of organizational interests, as well as participating in external inspections and audits, developing action plans, and ensuring their implementation. * Collaborate in planning, execution, and evaluation of the effectiveness of training on Good Distribution Practices, ensuring continuous staff updating. * Ensure management and updating of safety data sheets for marketed products (where applicable), guaranteeing full documentary compliance. * Supervise management and compliance of EMMs (Electronic Medical Records or related systems—context-dependent) in logistics platforms, ensuring traceability and documentary control. **Profile:** * Master’s degree in Pharmaceutical Sciences, registered with the Portuguese Pharmaceutical Society (mandatory); * Minimum 3–5 years’ professional experience in similar roles, particularly Technical Direction and Regulatory Affairs (preferred); * Advanced certification in Good Distribution Practices — MUH, MUVET, DMs and Cosmetics (valued); * Knowledge of applicable regulatory legislation, NP\-EN ISO 9001:2015 (valued); * Familiarity with Infarmed and DGAV platforms; * Experience interacting with regulatory entities, external audits and inspections (valued); * Strong technical analysis, decision-making, and priority management skills; * Excellent communication and interpersonal relationship skills; * High sense of responsibility, rigor, and attention to detail; * Residence in the Lisbon region. **We Offer:** * Integration into a solid organization with over 51 years of history and undergoing significant transformation; * A collaborative environment offering autonomy, continuous learning, and room for growth; * Opportunity to join a team that cares for, empowers, and celebrates People—the center of everything we do; * Competitive benefits package. **Here, the Technical Directorate has voice, impact, and future. Join us!**