Qualification and Validation Expert in GxP

vor 3 Wochen

Frankfurt am Main, Hessen, Deutschland Global Market Solutions GmbH Vollzeit
About the Role

We are seeking a highly skilled Qualification and Validation Specialist to join our team at Global Market Solutions GmbH. As a key member of our operations team, you will play a crucial role in ensuring the quality and compliance of 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
  • We are a growing company with ambitious targets that stands for expert knowledge, integrity, and open-mindedness.
  • As a consultant, you will implement a wide range of projects for our well-known customers and offer them your growing expertise.
  • Your development is supported by a coach, further training, our in-house learning platform, and an internal IT & data network.
  • Work-life balance is important to us - you enjoy home office options, have the choice between regional or Germany-wide projects, and our philosophy is a 40-hour week.
  • We also offer security and stability - our employees are employed on a permanent basis.

We are an equal opportunities employer and welcome applications from all qualified candidates. If you are passionate about quality and compliance, and have the skills and experience we are looking for, please submit your application.

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