Validation Lifecycle Expert
3 weeks ago
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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