GxP Training Lead
il y a 1 semaine
About Us
Besins 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 job
The main purpose of this cross functional position is :
- Implementation and coordination of GxP training activities across a global Pharmaceutical organisation, with management through an electronic Quality Management System.
- Preparation and delivery of GxP Trainings to all the involved global departments
Key Responsibilities:
Training needs mapping and coordination of GxP Trainings
Act as a Training manager on the harmonization of training needs of the Company:
- Identification and mapping of gaps and training needs for Corporate departments
- Implementing BH Quality Culture developing training strategy
- Maintain and ensure correctness of training community
- Coordination of training needs for BH stakeholders world-wide, driving compliance improvements projects, compliance gap analysis and impact assessment
Management
*of QMS Training System*
Act as Training Unit Admin for the electronic system in use
- Manage the electronic Training system.
- Coordinate the change control process related to the electronic Training system improvement
- Provide inputs in the harmonization process of the different business units using the electronic Training system
- Creating and maintaining training KPIs and trending
Management of Training System
Act as Training system Subject Matter Expert in Quality Projects
- Update and improve procedures.
- Ensure that annual training plans are prepared and fulfilled as per identified training needs
- Prepare training materials for GxP courses for the identified training needs
- Organize and deliver group trainings as per the annual plan
Regulatory Intelligence
- Maintain the GxP training in compliance with applicable regulations
- Monitor and inform of upcoming changes to regulatory intelligence across GxP activities.
Requirements
- Minimum of 5 years of relevant experience in GxP Areas and in training management
- Highly organized, outcome oriented, problem-solving, self-motivated, diligent person. -
- Understanding and/or working knowledge of standard GxP-QMS processes, related regulations, and pharmaceutical industry compliance practices.
- Understanding of IT systems supporting GxP activities.
- Objective focused, with ability to reach the expected result managing demanding situation
- Good 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
Interested? Please apply
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