Aktuelle Jobs im Zusammenhang mit Regulatory Compliance Specialist - Frankfurt am Main, Hessen - IT International Mobility


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Regulatory Compliance Specialist

vor 2 Monaten


Frankfurt am Main, Hessen, Deutschland IT International Mobility Vollzeit
Job Title: Qualification/Validation Specialist in GxP

At IT International Mobility, we are seeking a highly skilled Qualification/Validation Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring that all equipment, systems, and processes within our GxP-regulated environments are qualified and validated according to industry standards.

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.

We are an equal opportunities employer and welcome applications from all qualified candidates. We do not discriminate based on age, ethnicity, sexual orientation, gender, disability, or any factor other than merit. All applications with skills needed for the position are welcome.