We are seeking a highly skilled Quality Systems Specialist to join our team.
The role will involve enhancing our quality management systems, supporting the production of life-saving medicines and therapies. You will work collaboratively with cross-functional teams to ensure efficient QMS processes, meet internal and external client requirements, and support business growth.
* Collaborate as a solution-oriented team member to deliver QA objectives.
* Track and report metrics and key performance indicators for the Quality Management System.
* Support value-added improvements and key performance indicators with stakeholders.
* Review and follow-up on open actions related to Corrective and Preventative Actions (CAPA), Out of Specification (OOS) reports, and Deviations.
You will also be responsible for:
* Managing the Internal Audit program, including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights and initiatives to drive continuous improvement.
* Providing forward-thinking innovative solutions and identifying opportunities to add value to team deliverables.
* Assisting in the development of appropriate systems and processes to ensure delivery of information across functions to support enhanced performance culture.
* Document Control - Site lead for managing SOPs and Document Control.
Requirements
To succeed in this role, you will need:
* Minimum 3 years of professional experience in the pharmaceutical industry in a Quality Assurance focused role.
* Team Oriented: Ability to integrate with the organizational Core Values, culture, and team climate.
* Detail Oriented: Ability to focus on the details yet understand the overall direction.
* Self-Motivated: Identifying what needs to be done and doing it before being asked or before the situation requires it.
* Results Driven: The ability to focus on the desired result of one's own or one's unit's work, setting challenging goals, focusing effort on the goals, and meeting or exceeding them.
About Us
We offer a dynamic and supportive work environment that values innovation and collaboration. As a Quality Systems Specialist, you will have the opportunity to make a real impact on our organization and contribute to the production of life-saving medicines and therapies.