Pharmaceutical Validation Specialist

Vor 4 Tagen

Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

Are you a skilled professional looking for a new challenge in the pharmaceutical industry? We are currently seeking a Pharmaceutical Validation Specialist to join our team at GULP – experts united.

About the Job

  • Assume independent responsibility for the support of products in the context of process and cleaning validation, including representation in interdisciplinary project teams, compliance, and customer meetings.
  • Coordinate validation activities and plan process and cleaning validations, including the creation, maintenance, or revision of validation documents.
  • Conduct independent research and GMP-compliant evaluation of analytical and operational results and data.
  • Collaborate on control strategy, risk analysis, and other documents with the development unit, production, analytical units, or other relevant interfaces.
  • Evaluate changes in manufacturing/cleaning processes of products with regard to process and cleaning validation relevance.
  • Evaluate deviations with regard to process and cleaning validation relevance.
  • Represent validation topics in audits and inspections.

Requirements

  • Completed Master's degree in the natural sciences/technical field with several years of professional experience, or Bachelor's degree or completed scientific training with many years of professional experience in the GMP environment.
  • Several years of experience in the biopharmaceutical/pharmaceutical/process engineering field.
  • Comprehensive GMP knowledge and knowledge of regulatory requirements.
  • Very good PC skills in the common MS Office applications.
  • Experience with SAP and/or TrackWise is an advantage.
  • Fluent German and very good written and spoken English skills.
  • Very high degree of initiative, flexibility, and sense of responsibility.
  • An independent, structured way of working and a high level of commitment.
  • Assertiveness, communication, and teamwork skills, organizational skills, and social competence.
  • High quality awareness and willingness to acquire an understanding of process technology.

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