Quality Systems Specialist Job
This role is for a Quality Systems Specialist who will enhance the company's Quality Management System by collaborating with cross-functional teams. The successful candidate will be responsible for ensuring that QMS processes are efficiently maintained and conform to internal and external client requirements.
Job Description:
The Quality Systems Specialist will work alongside commercial and technical operations teams, delivering QA objectives to support business growth. This involves tracking and reporting metrics and key performance indicators for the Quality Management System, collaborating with stakeholders to identify value-added improvements, and reviewing open actions related to Corrective and Preventative Actions (CAPA), Out of Specification (OOS) reports, and Deviations.
Responsibilities:
1. Collaborate with cross-functional teams to maintain QMS processes.
2. Track and report metrics and key performance indicators for the Quality Management System.
3. Collaborate with stakeholders to identify and support value-added improvements.
4. Review and follow-up on open actions related to CAPA, OOS reports, and Deviations.
5. Support 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 for continuous improvement.
7. Provide forward-thinking solutions and identify opportunities to add value to the teams' deliverables.
8. Assist in developing systems and processes to ensure delivery of information across functions to support enhanced performance culture.
9. Document Control - manage SOPs and Document Control.
10. Manage quality training programs to ensure effective mirroring of HQ processes.
11. Site lead for training compliance to SOPs.
12. Other duties as required to support the growing Quality organisation.
Requirements:
* Minimum 3 years of professional experience in the pharmaceutical industry in Quality Assurance focused role.
* Adept at multi-tasking and working in a fast-paced environment.
* Strong, clear, and concise communication skills both internally and externally.
* Bachelor's degree in science, engineering, or business preferred.
* Willingness and availability to travel on company business.
* Team Oriented: Ability to integrate with organisational Core Values, culture, and team climate.
* Detail Oriented: Ability to focus on details while understanding overall direction.
* Self-Motivated: Identifying what needs to be done before being asked.
* Results Driven: Focusing on desired results and meeting goals.