QA Engineer
Quality Assurance Coordinator (Germany Based)
Ismaning
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In a few words đ
Position: QA Coordinator Germany
Location: Ismaning, Germany
Work model: Hybrid
Experience: 2â3 years of relevant experience, including at least 2 years in Quality Assurance or Quality Systems
Want to know more? đ
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? đ
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! đ
- 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? đ€
- University degree in Pharmacy or equivalent qualification.
- A Masterâs degree in Pharmaceutical Industry is an advantage.
- Fluent English, German, and Spanish.
- Minimum 2â3 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? đ”ïž
- Initial contact by phone or email.
- 1 to 2 interview stages, conducted virtually and/or onsite.
- Continuous communication during the process.
đ·Do you think this role is not for you? đ·
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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.
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