Global GMP Senior Quality Assurance Specialist

hace 3 semanas


Barcelona, Barcelona, España Novartis A tiempo completo

Job Summary
We are seeking an experienced Senior Quality Auditor to join our team at Novartis. The ideal candidate will have a strong background in GMP Audits and a proven track record of ensuring compliance with regulatory requirements.

Key Responsibilities

  • Lead and Conduct GMP Audits: Plan, lead, conduct, document, and follow-up on GMP audits according to Novartis Quality procedures and applicable regulations.
  • Provide Regulatory Guidance: Provide technical guidance, mentoring, and training on audit activities. Offer regulatory guidance for timely remediation and recommendations on acceptability of proposed filings.
  • Develop and Implement Audit Strategy: Support the development of an effective global risk-based audit strategy and program, including input into the audit strategy and plan.
  • Mentor and Train GMP Staff: Provide guidance and mentorship to junior GMP staff, including audit activities and regulatory compliance.
  • Ensure Compliance: Ensure that audit findings are properly addressed and that corrective action plans are implemented and reviewed.

Requirements

  • Experience: At least 12 years of experience in the pharmaceutical or medical device industry, with 3 years of auditing experience preferred.
  • Regulatory Knowledge: Strong knowledge of regulatory requirements, including GMP regulations and standards.
  • Leadership Skills: Excellent leadership and interpersonal skills, with the ability to manage and evaluate complex compliance issues.
  • Language Skills: Fluency in English, with additional languages a plus.


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