Department: Azzur IT, LLC
Basic Functions & Responsibility:
Reporting to the team leader of the Global Development Quality (GDQ) | Computer System
Validation (CSV) Center of Excellence (CoE), the consultant is responsible for QA oversight of
planning, execution, and summarization of CSV activities. The CSV activities requiring QA oversight will deal with a broad array of facility automation systems related to commissioning of a brand-new clinical manufacturing facility. The general requirement will be with the review of System Development Life Cycle (SDLC) deliverables for automation systems and equipment, automated facilities, and general QA expertise to support shop floor operations. The operations areas will initially deal with core building systems and oral solid dosage form manufacturing. Later in the building ramp up, sterile operations will come into the picture. More specifically, SDLC deliverables to be dealt with are User Requirements Specifications, Quality Assurance Plans, Functional Requirements Specifications, Configuration Specifications, Design Qualifications, supporting verification and/or testing against requirements (all types of testing documentation), Traceability Matrices, Quality Assurance Summary Reports, and Standard Operating Procedures. Various enterprise tools, such as electronic document management systems and digital test execution systems will be utilized.
The expectation is to provide leadership and direction to system project team members in a
wide variety of QA matters and specific regulatory matters dealing with data governance. The
incumbent will collaborate and participate on multiple teams and with multiple groups comprised of permanent employees and temporary non-client resources.
The position will ensure that all assigned projects achieve objectives within agreed-upon scope and time and that deliverables comply with stakeholder requirements and company policies.
- Participates, assists, and provides QA oversight in the development of SDLC deliverables
supporting GMP operations at the client site to ensure applicability and compliance with internal and external policy and regulations.
- Reviews various GMP deliverables for conformance with SDLC baseline criteria and other internal and external regulations.
- Identifies and resolves issues interfering with execution of deliverables. Implements practices designed to eliminate or minimize reoccurrences.
- Enforces Good Documentation Practices and ensures that SDLC deliverables are properly catalogued and available for internal and external regulatory inspection.
- Ensures that when documents are fully reviewed that approval by the QA representative does not require additional review or additional editing cycles.
Credentials & Skills:
- Bachelor’s degree in Computer Science, Engineering, Information Science, Mathematics, Life Science.
- Demonstrated mastery of computer systems validation and quality management systems principles in a GMP environment.
- Previous experience with pharmaceutical/biotech research and development including shop floor/operations setting (preferably clinical supply environment and preferably in QA).
- An experienced person with 5-8 years (minimum) of applicable experience
- Understanding of the automation and controls landscape and corresponding technologies/computing.
- Exceptional understanding of data governance and ALCOA principles.
- Demonstrated ability to negotiate and mediate quality assurance issues.
- Excellent written and oral communications and presentation skills.
- Demonstrated ability to analyze problems and identify and justify corrective and preventive actions.
- The ability to work independently with minimal supervision and/or oversight.
- Experience with SAP and MES although not required would be of additional interest.
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!