Equipment Qualification Specialist

Location: Princeton, NJ
Department: Azzur IT, LLC

Job Description

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!

Job Responsibilities
Responsible for ensuring compliance to the regulatory requirements of the facilities, utilities, equipment and analytical instruments qualification processes and activities performed in the East Hanover, NJ facility. Recommends and implements improvements of the qualification process. Performs a variety of routine and non-routine tasks related to facilities, utilities, equipment and analytical instruments qualification, as managing and overlooking qualification projects and changes. Prepares risk and impact assessments and other evaluations. Supports Process Unit (PU), Manufacturing, Science and Technology (MS&T), Operations (OPS), Quality Control (QC) and Quality Assurance (QA) departments.

 

Major Accountabilities:

  • Coordinates Qualification activities in compliance with corporate policy, local procedures and regulatory expectations
  • Coordinates and develops with PU, MS&T, OPS, QC and QA teams qualification projects and plans and identifies the “critical to quality” parameters impacting qualification activities
  • Prepares Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents
  • Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification programs
  • Conducts field execution of Installation, Operational, Performance Qualification and Computer System Validation (CSV) protocols
  • Assists PU, MS&T, OPS, QC and QA colleagues, as necessary
  • Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Company Policies
  • Determines Qualification requirements based on a worst case matrix approach for the site
  • Supports/assists 3rd party/ vendor qualification activities, if applicable
  • Support qualification/validation projects as allocated

 

Qualifications:

  • A Bachelors or Associates degree in a technical discipline is required
  • A minimum of 5 years of equipment qualification experience in a regulated environment, including CSV is required
  • Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: FDA, EMEA, OSHA, HS&E, etc.)
  • Manage, plan and schedule qualification activities with the System Owner(s) and third party service providers
  • Provide oversight and/or perform equipment and systems qualification, including CSV


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