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Validation Specialist for Pharma Processes

vor 3 Monaten


Bad Homburg vor der Höhe, Hessen, Deutschland customfield3 Vollzeit
Position Overview:

We are seeking a skilled professional to become part of our team as a GMP Validation Consultant. In this position, you will be tasked with the preparation of essential documentation for the qualification of pharmaceutical manufacturing equipment and executing qualifications at client locations. Your role will be pivotal in ensuring adherence to current GMP standards and fulfilling client specifications in both pharmaceutical and biotechnology initiatives. Collaboration with various stakeholders, including suppliers, engineers, and operational teams, will be a key aspect of your responsibilities.

Key Responsibilities:
  • Development of GMP risk assessments and qualification strategies
  • Planning and conducting qualifications for production machinery, cleanroom environments, and utility systems
  • Documentation and reporting of qualification outcomes
  • Evaluation of supplier documentation and management of supplier interactions
  • Ensuring compliance with GMP documentation standards for all activities
  • Management of changes and deviations in processes
  • Archiving and maintaining all relevant documentation
  • Providing support and expert advice to project teams regarding GMP matters
  • Completing quality assurance responsibilities
Qualifications:
  • Degree in natural sciences, pharmacy, chemical engineering, or a related field, or relevant experience in qualification/validation within the pharmaceutical sector
  • Familiarity with validation processes, particularly for computerized systems (CSV), is beneficial but not essential
  • Proficient in both German and English
  • Strong analytical abilities, proactive attitude, and adaptability
  • Ability to work independently with a high level of attention to detail
  • Willingness to travel as required

Success in this role hinges on effective collaboration, assertiveness, and strong communication skills. You should be capable of understanding client needs and showcasing leadership in client interactions.

What We Provide:
  • Diverse and engaging tasks within a dynamic workplace
  • Opportunities for professional growth in a rapidly expanding organization
  • Access to various internal training and development programs
  • A welcoming work environment that encourages innovative contributions
  • Modern office facilities equipped with ergonomic workspaces and multifunctional areas
  • Attractive recreational activities and team-building initiatives