Les 204 meilleures offres d'emploi : en tant que Industrie et Production, , à La Courneuve (octobre 2025)

Besins Healthcare

Global Quality Operations Specialist – Product Distribution

il y a 2 jours

Paris

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 position will be responsible for product distribution while under product it is considered: API, bulk and finish product. He/she will support the compliance of distribution activities as storage and transportation in compliance with the requirements of cGMP and GDP guidelines applicable for country / regions in scope. He/she will provide support in managing and maintaining various QMS elements (e.g. Complaints, CAPAs, Deviations, Change Controls, Documentation, Vendor Management activities) in compliance with regulation and corporate processes. This is a corporate cross functional role that will cover working in the global organisation. Key Responsibilities: Maintain GDP compliance • Drive GDP Compliance culture across the Organisation., • Work closely with Supply Chain team, RPs and Affiliates Quality representatives., • Provide GDP Compliance oversight of supply chain activities in all markets in accordance with international and local requirements., • Ensure Quality Agreements with site distributors, contractors and transport carriers are established and maintained., • Establish and periodically review the Bona-Fides for Vendors and Customers., • Identify opportunities of improvement/standardization in the purpose of continuous improvement of the system/process used across the organisation., • Prepare and maintain applicable KPIs. Quality Operations in E2E Supply Chain • Solve technical and operational problems in the field of her/his expertise based on existing policies and procedures., • Prepare, write and review quality documentation related to the supply chain activities, including Change Controls, non-conformances, CAPAs, validation documentation, procedures and specifications., • Ensure adherence to serialization and data integrity requirements and proactively informs SC about such requirements from the markets., • Support documentation and assessment of temperature excursions during shipments of goods., • Provide Quality Management System support to Supply Chain for managing quality records with focus on compliance with GDP regulations., • Manage and monitor Quality status of goods in ERP (API, Finished products). Risk management • Identifies and evaluates recognized risks connected with distribution and storage of medical products. Puts mitigation plans in place., • Review requests for shipment under quarantine. Support to Partner Cluster • Support Quality activities of Partner Clusters as first level quality contact for partners., • Maintain Quality Agreements in place with Partners., • Maintain Quality documentation of Partners Requirements • Pharmacist or Engineer with degree in Quality, Regulatory, • A minimum of 5 years of Quality/Compliance experience in EU/FDA & GDP regulated environment, • Relevant experience in warehouse operations, systems and supply chain activities, • Proficient in Microsoft office. Experience in ERP tools, • Strong communication skills, • Ability to work in an international matrix environment, • Fluent English skills required, French or other languages will be a plus, • In depth knowledge of GMDP;, • Able to create concise reports with appropriate level of details. technical writing capabilities Interested? Please apply

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