Key individual will align closely with Quality and Manufacturing teams to and help determine effective and efficient mechanisms to build compliance and quality into the technical solutions.
The individual will step into business analysis and project management duties for projects related to system enhancements, site implementations, and new technology adoption.
• Oversee and support implementation of new solutions, testing, management, troubleshooting, and administration of new and existing systems within laboratory and warehouse environment
• Collaborate with global IT colleagues and other stakeholders to support existing processes and technologies. Identify customer requirements, assess impact to the delivery of applications and other IT functions.
• Support delivery of IT services and coordination with local and global resources on the status of projects and support efforts.
• Manage and support tasks and deliverables related to Software Development Life Cycle (SDLC) phases for laboratory computer systems. Ensures that system implementations are in keeping with the relevant FDA / 21 CFR Part 11, GxP guidelines as well as internal policies and processes.
• Manage stakeholder expectations, project timelines, and deliverables for new projects
• Provide Technical support for current and new workflow enhancements
• Provide guidance on system design and technical configurations where capable
• Interface directly with various Business, QA and IT functional areas.
• Requires 4-7 years of strong project management skills to lead the deployment of the global projects Proven experience working in a highly regulated environment within the Pharmaceutical Industry.
• Extensive knowledge and experience of cGMP and its implementation to laboratory instrumentation and laboratory processes.
• Experience in 21 CFR Part 11, GAMP
• Bachelor’s degree required,
• Self-directed with ability to organize and prioritize work.
While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 44 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.