30 oct
|
Exeltis
|
España
In a few words ? Position: QA Coordinator Germany
Location:
Ismaning, Germany Work model: Hybrid
Experience:
2–3 years of relevant experience, including at least 2 years in Quality Assurance or Quality Systems Want to know more? ? Exeltis is an international pharmaceutical company focused on the development and commercialization of high-quality healthcare solutions. The company operates in a regulated environment with a strong commitment to compliance, quality standards, and continuous improvement across all relevant markets and business activities. We are currently seeking a QA Coordinator Germany to support Quality activities across affiliates/subsidiaries within scope and to contribute to the implementation and maintenance of effective Quality Systems in line with applicable regulatory and internal requirements. What are we looking for? ? The position is responsible for supporting compliance with GxP, regulatory, and internal Quality standards within affiliates/subsidiaries, with a particular focus on documentation management, technical quality agreements, third-party oversight, quality metrics, and support to local Quality teams. The challenge ?
• Ensure that suitable Quality Systems are established, implemented, and maintained in the markets within scope.
• Provide oversight to support compliance with local regulatory requirements and internal Quality policies.
• Manage Quality documentation, including procedures, reports, and related documents.
• Support regional and local Quality teams in the handling of significant Quality issues and Quality management documentation.
• Support the implementation of Quality training activities for affiliates/subsidiaries.
• Manage Quality Technical Agreements between third parties and Exeltis.
• Maintain appropriate oversight of third-party Quality activities in routine operations.
• Identify Quality-related risks and support the definition of mitigation measures.
• Develop and monitor Quality metrics for third-party organizations and marketing affiliates.
• Support the prioritization and monitoring of strategic Quality initiatives in affiliates and subsidiaries.
• Monitor relevant regulatory developments and support the promotion of Quality standards across the organization.
• Support the implementation of the Quality digitalization strategy in affiliates/subsidiaries. What do you need? ?
• University degree in Pharmacy or equivalent qualification.
• A Master’s degree in Pharmaceutical Industry is an advantage.
• Fluent English, German, and Spanish.
• Minimum 2–3 years of relevant professional experience in a comparable role.
• At least 2 years of experience in Quality Assurance or Quality Systems, preferably in manufacturing sites, distribution centers, and/or affiliates.
• Knowledge of cGMPs and cGDPs.
• Experience in Quality for Marketing Affiliates.
• Knowledge of Quality Assurance, Quality Control, and/or manufacturing processes.
• Good user knowledge of Microsoft Office.
• Willingness to travel occasionally. Additional
skills:
• Strong communication skills
• Structured and organized approach to work
• Ability to work under pressure
• Problem-solving capability
• Proactive attitude
• Reliability and persistence How will the selection process be? ?️
• Initial contact by phone or email.
• 1 to 2 interview stages, conducted virtually and/or onsite.
• Continuous communication during the process. ?Do you think this role is not for you? ? Please follow Exeltis on LinkedIn for future career opportunities. Equal Opportunity Commitment Exeltis is committed to equal opportunity, diversity, and non-discrimination. Applications are assessed exclusively on the basis of qualifications, experience, and job-related requirements, regardless of gender, gender identity or expression, ethnic origin, nationality, religion or belief, sexual orientation, age, disability, or any other characteristic protected by applicable law.
📌 Quality Assurance Coordinator (España)
🏢 Exeltis
📍 España