Quality & Compliance Specialist
Overview
In this role you will ensure quality and regulatory compliance across Life Sciences & Healthcare operations. You will maintain and improve the Quality Management System, support GDP/GMP/GAMP compliance, and drive audits, training, and customer relationships. You will work with cross-functional teams to implement quality policies and manage validation activities and quality agreements. This is an opportunity to influence quality standards at a global logistics leader and support patient safety through rigorous processes.
Responsabilità
- Maintain and continuously improve the Quality Management System
- Manage qualification activities for warehouses, cold rooms and temperature mapping
- Support GDP, GMP and GAMP compliance for Life Sciences & Healthcare operations
- Contribute to ISO 9001 and ISO 13485 certifications
- Coordinate and support validation activities for automated solutions
- Assist in customer audits, regulatory inspections and qualification visits
- Deliver training on quality processes, compliance requirements and GxP standards
- Support the definition and management of Quality Agreements with customers and suppliers
- Participate in new customer implementations, start-up projects and operational changes with quality impact
- Collaborate with Operations, Business Development and Project Management teams
- Support continuous improvement initiatives and alignment with DHL quality standards
Requisiti fondamentali
- Degree in Industrial Engineering, Pharmacy, Chemistry or related scientific field
- 2-5 years of experience in Quality Assurance, Quality Systems, Compliance or Regulatory roles
- Experience in Life Sciences, Healthcare, Pharmaceutical, Medical Devices or highly regulated industries
- Knowledge of GDP, GMP, GAMP and Quality Management Systems
- Understanding of ISO 9001 and ideally ISO 13485 standards
- Strong project management and stakeholder management skills
- Excellent communication and problem-solving abilities
- strong communication
- problem-solving
- stakeholder management
- GDP
- GMP
- GAMP
In this role you will ensure quality and regulatory compliance across Life Sciences & Healthcare operations. You will maintain and improve the Quality Management System, support GDP/GMP/GAMP compliance, and drive audits, training, and customer relationships. You will work with cross-functional teams to implement quality policies and manage validation activities and quality agreements. This is an opportunity to influence quality standards at a global logistics leader and support patient safety through rigorous processes.
Responsabilità
- Maintain and continuously improve the Quality Management System
- Manage qualification activities for warehouses, cold rooms and temperature mapping
- Support GDP, GMP and GAMP compliance for Life Sciences & Healthcare operations
- Contribute to ISO 9001 and ISO 13485 certifications
- Coordinate and support validation activities for automated solutions
- Assist in customer audits, regulatory inspections and qualification visits
- Deliver training on quality processes, compliance requirements and GxP standards
- Support the definition and management of Quality Agreements with customers and suppliers
- Participate in new customer implementations, start-up projects and operational changes with quality impact
- Collaborate with Operations, Business Development and Project Management teams
- Support continuous improvement initiatives and alignment with DHL quality standards
Requisiti fondamentali
- Degree in Industrial Engineering, Pharmacy, Chemistry or related scientific field
- 2-5 years of experience in Quality Assurance, Quality Systems, Compliance or Regulatory roles
- Experience in Life Sciences, Healthcare, Pharmaceutical, Medical Devices or highly regulated industries
- Knowledge of GDP, GMP, GAMP and Quality Management Systems
- Understanding of ISO 9001 and ideally ISO 13485 standards
- Strong project management and stakeholder management skills
- Excellent communication and problem-solving abilities
- strong communication
- problem-solving
- stakeholder management
- GDP
- GMP
- GAMP