Technical Management Cacém

Description

Job Summary: plural+udifar is seeking a Technical Director to ensure regulatory compliance, quality, and safety in pharmaceutical distribution operations. Key Highlights: 1. Integration into a solid and transforming organization. 2. Collaborative environment with autonomy and continuous learning. 3. Opportunity to have a voice, impact, and future within the Technical Management. **plural\+udifar**, a reference in the pharmaceutical distribution sector, is seeking a Technical Director who wishes to assume a central role in ensuring quality, safety, and technical integrity of an ever-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 (QMS), promoting continuous operational improvement. Also responsible for the regulatory framework and compliance of private-label services and products, ensuring coordination with regulatory authorities. **Responsibilities:** * Ensure compliance with Pharmaceutical Good Distribution Practices, Technical Management 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, in coordination with operational and commercial departments, guaranteeing regulatory compliance, quality, and safety of marketed products, including private-label brands 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 processes, 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 safeguarding organizational interests, as well as participating in external inspections and audits, preparing 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) in logistics platforms, ensuring traceability and documentary control. **Profile:** * Master’s degree in Pharmaceutical Sciences, registered with the Portuguese Pharmaceutical Society (mandatory); * Minimum professional experience of 3–5 years in similar roles, particularly Technical Management and Regulatory Affairs (preferred); * Advanced training certification in Good Distribution Practices \- MUH, MUVET, DMs, and Cosmetics (advantageous); * Knowledge of applicable regulatory legislation, NP\-EN ISO 9001:2015 (advantageous); * Familiarity with Infarmed and DGAV platforms. * Experience interacting with regulatory authorities, external audits, and inspections (advantageous); * Technical analytical ability, decision-making skills, and priority management; * Excellent communication and interpersonal relationship skills; * Strong 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; * 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, Technical Management has a voice, impact, and future. Join us!**