Validation Consultant III/Deviations Investigations

Location: Summit, NJ
Department: Azzur Princeton, LLC

Job Description

Deviation resolution and management:
• Categorize deviations by workstream/ track i.e., manufacturing, qc, etc.
• Prioritize deviations by criticality/ i.e., impact, schedule, etc.
• Distill sorting by product, batch, equipment, etc.
• Develop standard process to streamline activities.
• Consolidate deviations with like-root cause only if possible.
• Develop project plan and schedule in alignment with client objectives.
• Perform investigations, root cause analysis, and determine impact (when necessary).
• Collect relevant and related data, records, documentation, and host interviews with identified client resource (as appropriate).
• Author, Revise, and Review supporting GMP documentation (SOPs, work instructions, workflows, and related records)
• Perform thorough quality checks and peer-reviews.
• Route documents for review and approval through QMS.
• Inform project stakeholders of progress, delays, or bottlenecks to collaborate and devise a solution when necessary
• Establish relationships with project stakeholders, project team, and workstream champions
• Identify escalation process for rapid responses and decisions

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

Apply Now

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