Quality Management System Specialist
Job Description:
- Support development, implementation and management of Quality Management System (QMS) and related
- processes to ensure adherence to regulatory and Client requirements.
- Collaborate with Global Quality Organizations to identify and implement system enhancements.
- Participate in testing and verification of new and revised system functionality/enhancements.
- Enter and update system list of values timely, as needed.
- Support testing and training activities as needed for system implementations and or enhancements.
- Work cross-functionally to support the creation and revision of policies and procedures in support of Client Quality Systems.
- Manage user change requests and change process.
- Gather user requirements and work with technical personnel to define the appropriate configuration for IT Systems to meet defined business requirement.
- Consult with management and business process owners to ensure QMS system is aligned with user requirements
- Create reports and metrics for users.
- Provide regular updates on project progress and escalate challenges as needed.
- Train end users on the use of new and updated Quality business process, system, policies and procedures.
- Other duties as assigned
Other Qualifications:
- Understanding of Quality best practices, including familiarity with Quality Systems Regulations, GxPs, and applicable ISO Standards
- Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs).
- Excellent attention to details
- Ability to effectively manage time and progress tasks to meet timeline in a fast pace/dynamic environment
- Effective oral and written communication skills
- Experienced working cross-department with Quality, IT, Clinical, Regulatory and Development.
- Working knowledge of business process and process improvement
- Experienced interfacing with external software vendors.
- Experienced in managing projects towards process improvements.