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Expert in Pharmaceutical Equipment Qualification

vor 2 Monaten


Crailsheim, Baden-Württemberg, Deutschland groninger Vollzeit
About the Role

We are seeking a highly skilled and experienced professional to join our team at Groninger as a Pharmaceutical Equipment Qualification and Validation Specialist. In this role, you will be responsible for ensuring the quality and compliance of our pharmaceutical equipment and processes.

Key Responsibilities
  • Equipment Qualification and Validation: Develop and implement qualification and validation plans for pharmaceutical equipment, ensuring compliance with Good Manufacturing Practice (GMP) regulations.
  • Dokumentation and Reporting: Create and maintain accurate and detailed documentation of qualification and validation activities, including risk analyses, test plans, and reports.
  • Customer Workshops and Training: Design and deliver customer workshops and training sessions to ensure effective communication and understanding of qualification and validation processes.
  • Regulatory Compliance: Collaborate with cross-functional teams to ensure regulatory compliance and adherence to GMP regulations.
  • Test Planning and Execution: Develop and execute test plans to validate equipment performance and ensure compliance with GMP regulations.
  • Internal and External Consultations: Provide expert advice and guidance on qualification and validation processes to internal and external stakeholders.
Requirements
  • Education: Bachelor's degree in a relevant field, such as mechanical engineering, electrical engineering, or pharmaceutical technology.
  • Experience: Proven experience in a regulated environment, with a focus on qualification and validation.
  • Technical Expertise: Strong technical knowledge and analytical skills, with the ability to interpret complex data and regulations.
  • Communication and Teamwork: Excellent communication and teamwork skills, with the ability to work effectively with cross-functional teams.
  • Language Skills: Fluency in German and English, with excellent written and verbal communication skills.
  • Travel Requirements: Ability to travel internationally, with occasional overnight stays.