Quality Assurance Coordinator (Germany Based Relocation Required)

Insud Pharma

Comunidad de Madrid

Presencial

EUR 55.000 - 75.000

Jornada completa

Hace 3 días
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Descripción de la vacante

Exeltis is seeking a QA Coordinator to support quality activities across affiliates/subsidiaries and contribute to the implementation and maintenance of effective Quality Systems. You will help ensure compliance with GxP and regulatory standards and manage documentation and third‑party quality agreements.

The role focuses on supporting regional and local Quality teams, overseeing quality metrics, and promoting quality training and digitalization initiatives across the organization.

Formación

  • University degree in Pharmacy or equivalent qualification.
  • Master’s degree in Pharmaceutical Industry is an advantage.
  • Fluent English, German, and Spanish.

Responsabilidades

  • Support compliance with GxP, regulatory and internal Quality standards within affiliates/subsidiaries.
  • Manage Quality documentation, procedures, reports and related documents.
  • Support Quality teams in handling issues and quality management documentation.

Conocimientos

Fluent English
German
Spanish
Quality Assurance
Documentation

Educación

Pharmacy degree
Master's in Pharmaceutical Industry

Herramientas

Microsoft Office

Descripción del empleo

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.

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