Quality Assurance Specialist

Vor 4 Tagen

Visp, Schweiz Capgemini Engineering Vollzeit
Job Description

We are seeking a highly skilled Quality Assurance Specialist to join our team at Capgemini Engineering.

Key Responsibilities:
  • Provide comprehensive quality assurance oversight for commissioning, qualification, and validation activities, ensuring adherence to regulatory guidelines and company standards.
  • Review and approve all CQV documentation, including protocols (IQ, OQ, PQ), validation reports, test scripts, Standard Operating Procedures (SOPs), and validation master plans, ensuring accuracy and compliance.
  • Conduct quality-focused risk assessments and collaborate with teams to develop and implement mitigation strategies to address identified risks in CQV activities.
  • Actively participate in audits by internal and external regulatory bodies, providing QA support for CQV documentation and addressing any audit findings.
  • Evaluate and approve changes to qualified systems, equipment, and processes, ensuring ongoing compliance with validation requirements.
  • Lead investigations into quality-related issues identified during CQV activities and ensure the timely implementation of Corrective and Preventive Actions (CAPAs).
  • Identify and implement improvements in QA processes related to CQV to enhance efficiency, compliance, and overall quality.
Requirements
  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • 5+ years of experience in QA roles with a strong 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 analytical and problem-solving skills, with a focus on quality and compliance.
  • Proficiency in technical writing for quality documentation and regulatory submissions.
  • Strong interpersonal and communication skills to work effectively with cross-functional teams.
  • Ability to prioritize and manage multiple tasks in a fast-paced environment.
  • Fluency in English.

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