Quality Manager ?Warehousing and Logistics

Description

Quality Manager -Warehousing and Logistics

Our global pharmaceutical client is looking for a QA Manager to support their highly automated warehouse based in South West Germany. The Quality Assurance Manager will provide leadership and management for Quality Assurance activities at the Warehouse/Logistics site to ensure that Quality Systems and products are effective and in compliance with regulatory expectations and quality standards.
Key Responsibilities:
• Ensure compliance to regulatory requirements including quality management systems standards i.e. ISO 9001, ISO 13485, and FDA.
• Ensure that validation system is in compliance with relevant external (regulatory) requirements including GMP and FDA.
• Maintenance, development and documentation of the quality management in the international logistics centre.
• Monitor product changes through the Change Management System, to ensure compliance.
• Coordination and implementation of complaints and product recalls including implementation of corrective action process where required.
• Continuous process assurance and optimisation for quality management and quality systems.
• Analysis of business processes and coordination of all quality-related activities.
• Prepare the site for, and host, external audits (customer/regulatory) ensuring corrective/preventative actions are put in place to address non-conformances.
• Participation in various working groups and project groups in business organisations, possibly led by cross-departmental projects
Candidate Requirements: •


• University degree, ideally in the field of medical technology, mechanical engineering, business administration or equivalent experience.
• Some experience of a logistics and warehousing environment as QA manager.
• Extensive experience in the field of quality management
• Knowledge in the relevant quality assurance standards (GMP and FDA)
• Experience in the implementation of national legislation and international standards
• Meticulous and detail-oriented approach
• Team player who is experienced in gaining internal and external stakeholder buy-in.
• Fluent English and German langue skills required.