Senior Quality Engineer

Vor 6 Tagen

Visp, Schweiz Capgemini Engineering Vollzeit
About the Role

This Senior Quality Engineer position is an exciting opportunity to contribute to the success of Capgemini Engineering.

Key Responsibilities:
  • Develop and execute comprehensive quality assurance plans to ensure compliance with regulatory requirements and company standards.
  • Collaborate with cross-functional teams to identify and implement process improvements, reducing risks and enhancing overall quality.
  • Analyze data and trends to inform quality-focused decision-making and drive continuous improvement initiatives.
  • Communicate complex quality-related information to stakeholders, both verbally and in writing.
  • Develop and maintain quality documentation, including SOPs, procedures, and training materials.
  • Participate in audits and inspections, providing QA support and ensuring compliance with regulatory requirements.
  • Maintain current knowledge of regulatory requirements, industry best practices, and emerging trends in quality management.
Requirements
  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • 7+ years of experience in QA roles, with a focus on CQV activities within the pharmaceutical or biotechnology industry.
  • In-depth knowledge of CQV processes, including IQ, OQ, and PQ, as well as associated regulatory requirements.
  • Familiarity with cGMP, FDA, EMA, and ICH guidelines, with proven experience in ensuring compliance.
  • Strong leadership and collaboration skills, with the ability to motivate and guide cross-functional teams.
  • Excellent communication and interpersonal skills, with the ability to build relationships with stakeholders at all levels.
  • Ability to prioritize and manage multiple tasks in a fast-paced environment.
  • Fluency in English.

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