Essential Duties and Responsibilities:
Prepare CSV SOP's, and related CQV deliverables obtaining guidance from Information Technology and applicable departments.
Develop, review and perform appropriate testing strategies and standards and provide input on all CSV activities and documentation requirements, including but not limited to: Validation Master Plans, Validation Risk Assessments, Validation Project Plans, User/Functional Requirement/Design/Configuration Specifications, Qualification Protocols, Validation Final Report, and Change Controls/Compliance Reviews
Review/audit and/or approve key validation deliverables and change management deliverables for computerized systems as well as oversee testing and validation activities and assure quality of documentation
College degree in technical discipline or equivalent work experience; and five plus years of computer system validation experience in an FDA or related regulatory environment. Experience with SOP authoring and SaaS/Paperless systems (e.g. Veeva) validation preferred.
Effective organization, project management, problem-solving, training/coaching, and conflict resolution and interpersonal skills and the ability to manage priorities in a time sensitive environment
Proficiency using computer software and systems including MS Office and MS Office, Visio and PowerPoint
Siemens, Rockwell, Wonderware, LabX, SAP, ControlLogix experience a plus
Detailed knowledge of quality assurance and validation regulations, guidelines and standards (e.g. FDA, GAMP), as well as, Industry Standard Validation Best Practices (e.g. COBIT)
Ability to plan for, coordinate, and conduct reviews of project deliverables for completeness, quality, and compliance with established project standards
Strong written/verbal communication and presentation skills and the ability to communicate effectively at all levels.
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!