Senior QMS Admin
1 week ago
JOB DUTIES:
The Quality Management System (QMS) Administrator is responsible for supporting administrative tasks associated with QMS processes, including Corrective and Preventive Actions (CAPA), Audits, and other QMS-related activities. This role requires strong attention to detail, the ability to communicate, and a willingness to adapt to changing business needs.
Responsibilities May Include Some Or All Of The Following
- Acts in an administrative support capacity for critical QMS processes such as CAPA and audits.
- Review quality records for all related areas of responsibility.
- Responsible for personal daily task management, training plans, and performance management.
- Supports the creation, review, and maintenance QMS documents.
- Provide administrative support for external audits (regulatory or customer).
- Perform User Acceptance Testing (UAT) for electronic Quality Management Systems (eQMS)
Pre-requisites
- Vocational, Associate or bachelor's degree in business administration, scientific discipline, or equivalent experience.
- 1+ years of Quality Management System (QMS) experience working in a regulated Good Manufacturing Process (GMP) environment
- Advanced knowledge of Microsoft Office applications, especially Word and Excel.
Personal competencies
- Capacity to work both independently and in a team-oriented environment
- Ability to effectively complete the tasks entrusted
- Capacity to quickly adapt to changing priorities and timelines
- Strong oral and written communication skills
- Ability to learn quickly and pay attention to detail
Optional competencies
- Practical experience in a regulated industry
- Knowledge of international standards such as ISO 13485
- Knowledge of regulatory requirements related to medical devices (Health Canada, FDA, TGA, etc.).
- Other responsibilities as needed.
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