Job Description
About UsBesins Healthcare, founded in 1885, is a global, family-owned pharmaceutical company specializing in medical-grade hormones. With expertise in gynaecology, fertility, obstetrics, endocrinology, and hormone deficiency treatments, we are dedicated to advancing reproductive hormone therapies that support lifelong health and well-being.Our multicultural team of more than 1,500 employees, across 22 affiliates and 5 production sites, supports our presence in over 90 countries. Together, we continue to grow through innovation, expanding our products into new territories, and building strong partnerships worldwide.Purpose of the jobThe main purpose of this cross functional position is implementation and coordination of training activities across a global GxP organisation, with management through an electronic training system.This role will also include contribution to organization and handling of the training activities for corporate depts. and regulated BH entities in a collaborative work with other global departments (e.g., Supply Chain, Medical Organisation, Information Technology, Pharmacovigilance and Pharmaceutical Affairs).Key Responsibilities:Training needs mapping and coordination of GxP TrainingsIdentification and mapping of gaps and training needsImplementing BH Quality Culture developing training strategyCoordination of training needs for BH stakeholders world-wide, driving compliance improvements projects, compliance gap analysis and impact assessmentSupport the start-up of new BH Units in using Ennov Training module and implementation of new training processes, training materials and training modules.Management of Training SystemAct as Training system Subject Matter Expert in Quality ProjectsManage the electronic Training system.Maintain and ensure correctness of training communityTrain a deputy Administrator of Ennov Training ModuleMaintain training KPIs preparation and trendingUpdate and improve procedures.Administration of Quality Master DataMapping and collection of Master Data needed for Quality Dept. including Besins products, suppliers, and customersCross-check of reliability of the info received by BH stakeholdersCreate and maintain a suitable database and update relevant lists accordinglyAudits and supplier management supportParticipate in audits to Besins suppliersWork on the risk assessment for BH suppliers and customer to implement a risk-based approachCoordinate the BH stakeholders on collection of information about Supplier Management to improve a sustainable and monitoring processRegulatory IntelligenceMonitor and inform of upcoming changes to regulatory intelligence across GXP activities.Ensure that Regulatory Intelligence process is in place.RequirementsMaster's degree in pharmaceutical or scientific areasMinimum of 3 years of relevant experience in GxP Areas.Understanding and/or working knowledge of standard GxP-QMS processes, related regulations, and pharmaceutical industry compliance practices.Highly organized, outcome oriented, problem-solving, self-motivated, diligent person.Understanding of IT systems supporting GxP activities.Objective focused, with ability to reach the expected result managing demanding situationGood written and verbal communication skills to build strong customer relationships and deliver solutions.Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.Team worker able to create a climate where people are motivated to help the organization achieve its objective in an international environment
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