At the forefront of MedTech innovation, our team is expanding its Quality Assurance capabilities with a Quality Systems Specialist. This key role will concentrate on refining and enhancing our Quality Management System (QMS), thereby supporting global pharmaceutical companies in producing life-saving medicines and therapies.
The ideal candidate will collaborate closely with our cross-functional teams to maintain QMS processes efficiently. Key duties and responsibilities include:
* Collaborating with the commercial and technical operations teams to deliver QA objectives and support business growth;
* Tracking and reporting metrics and key performance indicators for the QMS;
* Collaborating with stakeholders to identify value-added improvements and key performance indicators;
* Reviewing and following up on open actions related to CAPAs, 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 and initiatives to drive continuous improvement;
* Providing forward-thinking innovative solutions and identifying opportunities to add value to the teams' deliverables;
* Assisting in developing appropriate systems and processes to ensure information delivery across functions and support enhanced performance culture;
* Document Control: managing SOPs and Document Control; and
* Managing quality training programs to ensure they effectively mirror what is in place at HQ.
This role requires:
* Minimum 3 years of professional experience in the pharmaceutical industry in a Quality Assurance focused role;
* Team Oriented: ability to integrate with organizational Core Values, culture, and team climate;
* Detail Oriented: ability to focus on details while understanding 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: ability to focus on desired results, setting challenging goals, focusing effort on goals, and meeting or exceeding them;
* Adept at multi-tasking and working in a fast-paced environment;
* Strong, clear, and concise communicator both internally and externally with pharmaceutical clients;
* Bachelor's degree in science, engineering, or business preferred; and
* Willingness and availability to travel on company business.
For more information about this role, please contact Chris O Toole at 091 706 713.