Quality Assurance Coordinator (Germany Based)

Exeltis; Ismaning; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Exeltis is seeking a QA Coordinator for Germany to support quality activities across affiliates and to contribute to the effective Quality Systems in line with regulatory requirements.

The role focuses on documentation management, third-party oversight, quality metrics, and training support for local Quality teams. Travel to affiliated sites may be required, and English, German, and Spanish fluency is expected.

Qualifikationen

• University degree in Pharmacy or equivalent qualification.
• 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.

Aufgaben

• Support compliance with GxP, regulatory, and internal Quality standards within affiliates/subsidiaries, focusing on documentation management.
• Oversee Quality agreements, third-party oversight, and quality metrics.
• Support local Quality teams and implementation of Quality training activities.
• Maintain Quality documentation and procedures across markets.
• Assist in handling significant Quality issues and related management documentation.
• Support Quality digitalization initiatives across affiliates.

Kenntnisse

Quality Assurance

Quality Systems

Documentation management

Quality metrics

Regulatory compliance

GxP

Microsoft Office

Travel willingness

Ausbildung

Bachelor's degree in Pharmacy or equivalent

Master's degree in Pharmaceutical Industry (advantage)

Tools

Microsoft Office

Jobbeschreibung

Experience: 2-3 years of relevant experience, including at least 2 years in Quality Assurance or Quality Systems

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:

• Structured and organized approach to work
• Ability to work under pressure
• Problem-solving capability
• 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.

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.