Quality Systems Specialist Job Summary
This exciting opportunity allows the successful candidate to take on a key role in our MedTech facility's QA Team.
The Role:
You will be responsible for enhancing our Quality Management System, supporting global pharma in the production of life-saving medicines and therapies. This involves maintaining QMS processes efficiently, ensuring conformity to internal and external client requirements, and engaging with cross-functional teams to improve our QMS and support our clients' processes.
Main Responsibilities:
1. Collaborate as a solution-oriented team member to deliver QA objectives that support business growth.
2. Track and report metrics and key performance indicators for the Quality Management System.
3. Work with stakeholders to identify and support value-added improvements and key performance indicators.
4. Review and follow-up on open actions related to Corrective and Preventative Actions (CAPA), Out of Specification (OOS) reports and Deviations.
5. Support and host Client quality audits, addressing findings and required actions.
6. Manage the Internal Audit program, including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights to drive continuous improvement.
7. Provide forward-thinking innovative solutions and identify opportunities to add value to the teams' deliverables.
8. Assist in developing appropriate systems and processes to ensure delivery of information across functions to support an enhanced performance culture.
9. Document Control - Lead management of SOPs and Document Control.
10. Manage quality training programs at the site to ensure they effectively mirror what is in place at HQ.
11. Lead training compliance to SOPs.
12. Other duties as required to support the growing Quality organisation.
Requirements:
13. Minimum 3 years of professional experience in the pharmaceutical industry in Quality Assurance focused role.
14. Adept at multi-tasking and working in a fast-paced environment.
15. Strong, clear, and concise communication both internally and externally with pharmaceutical clients.
16. Bachelor's degree in science, engineering, or business preferred.
17. Willingness and availability to travel on company business.
18. Team-oriented: Ability to integrate with the organisational Core Values, culture, and team climate.
19. Detail-oriented: Ability to focus on details yet understand the overall direction.
20. Self-motivated: Identifying what needs to be done and doing it before being asked or before the situation requires it.
21. 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.