Job Description
We are seeking a Quality Systems Specialist to join our team. As the Quality Systems Specialist, you will play a key role in enhancing our Quality Management System.
As a member of our QA Team, you will be responsible for ensuring that our QMS processes are efficiently maintained and conform to internal and external client requirements.
You will engage cross functionally with exceptional SME team members to enhance our QMS and support our Client's processes.
The ideal candidate will have a 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 is a must.
Strong, clear and concise communicator both internally and externally with pharmaceutical clients is also required.
Bachelor's degree in science, engineering or business is preferred.
Frequent travel on company business may be required.
Key Responsibilities
1. Collaborate as a solution-oriented team member to work alongside the commercial and technical operations teams, delivering QA objectives to support business growth.
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 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 / host Client quality audits. Inclusive of addressing findings and required actions.
6. Management of the Internal Audit program including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights and initiatives to drive continuous improvement.
7. Provide forward thinking innovative solutions and identify opportunities to add value to the teams' deliverables.
8. Assist in the development of appropriate systems and processes to ensure delivery of information across functions to support enhanced performance culture.
9. Document Control - Site lead for managing SOPs and Document Control.
10. Manage quality training programs at site to ensure these effectively mirror what is in place at HQ.
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 communicator both internally and externally with pharmaceutical clients.
* Bachelor's degree in science, engineering or business preferred.
* Frequent travel on company business may be required.
Skills and Qualifications
The ideal candidate will possess:
* 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.