We are seeking a highly skilled Quality Systems Specialist to enhance our Quality Management System. The successful candidate will be responsible for ensuring that QMS processes are efficiently maintained and conform to internal and external client requirements.
About the Role
The Quality Systems Specialist will work collaboratively with cross-functional teams to identify and implement process improvements. Key responsibilities include:
* Collaborating with commercial and technical operations teams to deliver QA objectives and support business growth;
* Tracking and reporting metrics and key performance indicators for the Quality Management System;
* Collaborating with stakeholders to identify value-added improvements and key performance indicators;
* Reviewing and following up on open actions related to CAPA, OOS reports, and Deviations;
* Supporting and hosting Client quality audits, including addressing findings and required actions;
* Managing the Internal Audit program, including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights to drive continuous improvement;
* Providing innovative solutions and identifying opportunities to add value to team deliverables;
* Assisting in the development of 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;
* Managing quality training programs at Castlebar site to ensure effective mirroring of HQ processes;
* Site lead for training compliance to SOPs.
Requirements
To be successful in this role, you will need:
* Minimum 3 years of professional experience in the pharmaceutical industry in Quality Assurance focused roles;
* Adept at multi-tasking and working in fast-paced environments;
* Strong, clear, and concise communication skills both internally and externally with pharmaceutical clients;
* Bachelor's degree in science, engineering, or business preferred;
* Willingness and availability to travel on company business;
* Team Oriented: Ability to integrate with organizational Core Values, culture, and team climate;
* Detail Oriented: Ability to focus on details yet understand 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 desired results of one's own or one's unit's work, setting challenging goals, focusing effort on goals, and meeting or exceeding them.