Aktuelle Jobs im Zusammenhang mit GxP Validation Specialist - Frankfurt am Main, Hessen - IT International Mobility


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GxP Validation Specialist

vor 2 Monaten


Frankfurt am Main, Hessen, Deutschland IT International Mobility Vollzeit
{"title": "Qualification and Validation Specialist in GxP", "description": "Job Summary

We are seeking a highly skilled Qualification and Validation Specialist to join our team in Frankfurt, Rhine-Main Area. As a key member of our International Mobility Recruitment Department, you will be responsible for ensuring the qualification and validation of equipment, systems, and processes within our GxP-regulated environments.

Key Responsibilities
  • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems in compliance with GxP guidelines.
  • Conduct process validation and equipment qualification activities to ensure that all manufacturing, laboratory, and IT systems meet regulatory requirements.
  • Develop and review validation protocols, reports, and standard operating procedures (SOPs).
  • Collaborate with cross-functional teams, including Quality Assurance (QA), Engineering, and Production, to ensure smooth validation processes.
  • Perform risk assessments to identify potential risks and implement appropriate controls to mitigate those risks.
  • Maintain thorough documentation of all qualification and validation activities in compliance with GxP standards.
  • Ensure adherence to GAMP 5, GMP, and other relevant regulatory requirements during all validation projects.
  • Support internal and external audits by providing validation documentation and addressing any queries related to validation activities.
  • Monitor and address any deviations, non-conformances, or changes in validated systems and processes.
Requirements
  • Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
  • 2-3 years of experience in validation and qualification of equipment in a GxP-regulated environment
  • Strong knowledge of GMP, GAMP 5, and other regulatory requirements.
  • Experience with validation documentation, including writing and reviewing validation protocols and reports.
  • Familiarity with risk management tools (e.g., FMEA) and approaches in validation.
  • Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously.
  • Strong organizational, communication, and problem-solving skills.
  • Attention to detail and a commitment to maintaining high standards of quality and compliance.
  • Prior experience in a German-speaking GxP environment (mandatory)
  • Experience with computer system validation (CSV) and IT system qualifications (is a plus)
  • Native in German (mandatory)
  • Residency in Germany, with the ability to work in a hybrid model from Frankfurt, Rhine-Main Area
What We Offer
  • International Mobility: Access to a dedicated international mobility department with personalized relocation programs to facilitate your move to a new country.
  • Career Development: Opportunities to work on projects with cutting-edge technologies in different countries and various sectors.
  • Continuous Learning: Access to ongoing and free training and career-oriented certifications.
  • Personal Growth: Exchange of ideas and best practices among professionals across Europe, fostering creativity and innovation in IT.
  • Global Citizen in the World of Technology: Opportunity to work in a global network of companies, with access to a wide range of challenging projects in different European markets.
About Us

We are a leading group in Engineering and Information Technology (IT) across Europe and North Africa, with a presence in 14 countries and over 9,500 talents. We value diversity and equality, and we create a safe and inclusive environment where opportunities are equal for everyone.

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