The position is responsible for the implementation of and review of the eQMS (electronic Quality Management System) strategy. This responsibility includes ensuring that the global Computer System Validation (CSV) program is compliant with all applicable global regulatory requirements. Perform interim and final quality assurance reviews of all training products, including design documentation and multimedia products. Review interactive operator/maintainer training courseware and simulations, at various stages of development to ensure they meet quality standards, function properly, and accurately represent scripts and storyboards. Prepare required forms for product deliveries. Review training feedback documentation for recommendations. Collect and report on production and delivery metrics. Must be familiar with ValGenesis Validation Lifecycle Management System.
Quality Systems
- Responsible for the oversight, performance, effectiveness, and compliance with applicable regulations of electronic QMS utilized to support agreed upon Business Units
- Propose and execute implementation of the electronic QMS throughout the global network, per value-driven strategy that prioritizes productivity & efficiency gains
- Responsible for the global Computer System Validation (CSV) Program to ensure that relevant computer systems follow applicable regulations including GAMP 5, FDA 21 CFR Part 11, and Annex 11. This includes the validation of new global computer systems; evaluating and performing periodic reviews of existing validated computer systems to ensure/ verify continued compliance with appropriate regulations
- Compliance oversight and support of computer system change control process by determining validation or re-validation requirements and defines qualification strategy
- Deliver QMS standardization across pre-determined QMS modules by ensuring that the eQMS (Etq) design supports all required operations and does so in a compliant manner.
QUALIFICATIONS (Education/Training, Experience and Certifications)
- Requires a Bachelor's degree in sciences or scientific related field
- Masters degree in sciences or scientific related field preferred.
- Minimum of 8 years of progressive experience in Quality, Manufacturing, Operations, Quality Systems, and CSV. Proven track record of successfully operating in a regulated environment.
- Experience in influencing and / or managing others in a highly matrixed, regulated industry. Proven track record of delivering results in a complex, un-integrated, emerging quality maturity organization.
- Practical knowledge of compliance with cGDP’s, cGMP’s, and all Regulations applicable to the FDA and comparable international regulatory agencies within the biopharma and excipients production space.
- Experience in optimizing, qualifying, validating, transferring and troubleshooting analytical processes.
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
- Working knowledge of: FDA regulations, ISO, GAMP 5, 21 CFR Part 11, Annex 11 requirements amongst others
- Experience with Valgenesis, MasterControl, ProCal and LIMS
- Strong interpersonal skills with the ability to influence others and gain their buy-in on issues or in situations where there is no direct line of authority
- Excellent leadership, decision-making and analytical skills that manifest themselves in clear communications and excellent presentation of complex materials and matters.
- Experience with organization-wide introduction of a system / platform where cross-functional collaboration and effective communication were key to a successful pilot / launch / introduction
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!