Validation Lifecycle Expert

3 weeks ago


Los Angeles, California, United States Azzur Group Full time
About the Job

We are seeking a highly skilled Validation Lifecycle Expert to join our team at Azzur Group. As a key member of our quality assurance team, you will play a crucial role in ensuring the highest standards of quality in the pharmaceutical and biotechnology sectors.

About Us:

Azzur Group is a leading provider of GxP compliance and consulting services. Our mission is to provide quality-driven solutions that propel life science companies toward success.

Key Responsibilities:

  • Develop and implement validation processes that align with quality assurance principles and best practices.
  • Apply advanced statistical tools and methodologies to analyze validation data and inform decision-making related to quality outcomes.
  • Provide subject matter expertise during regulatory audits and inspections, ensuring all validation records and documentation are compliant and readily available.
  • Mentor and guide junior validation engineers, promoting a culture of knowledge sharing and professional growth.

Requirements:

  • Bachelor's degree in Engineering, Life Sciences, or a related field; a Master's degree is a plus.
  • 8+ years of experience in quality validation within the biotech or pharmaceutical industry.
  • Proven experience in regulatory compliance and quality assurance practices, specifically in validation activities such as IQ, OQ, PQ, and process validation.
  • Strong communication skills, both verbal and written, with the ability to effectively present validation data, findings, and recommendations to stakeholders.
  • Experience with major equipment validation, including tanks, filter presses, centrifuges, utilities, and facilities.
  • Strong knowledge of regulatory guidelines (FDA, EMA, cGMP, ISO) and industry standards specific to validation.
  • Excellent analytical and problem-solving skills, with a demonstrated ability to address complex challenges in validation processes.
  • Proficient in statistical analysis software and tools to support validation activities.

Estimated Salary: $150,000 - $190,000 per year



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