Job Description:
The Quality System Specialist plays a pivotal role in maintaining site compliance with regulatory requirements and company expectations.
Responsibilities:
1. Ensure compliance with all quality aspects for the Raheen site, including manufacturing, quality systems, quality control, validation, facilities, and materials management.
2. Maintain regulatory compliance according to current Good Manufacturing Practices (cGMP).
3. Collaborate with cross-functional teams to resolve issues, complete investigations, and maintain compliance.
4. Review and approve documents such as Failure Investigations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOPs), GxP documents, and Change Control documents.
5. Review system records for assignment, compliance, and closure.
6. Provide administrative support for electronic systems.
7. Review procedures, policies, and instructional documents related to quality systems to ensure compliance with company policy and local and international regulatory requirements.
8. Monitor and report on trending metrics associated with site quality systems.
9. Participate in continuous improvement initiatives, initiating and implementing ideas.
10. Participate in internal, regulatory, and customer audits.
11. Train personnel on quality system processes.
12. Supervise team members.
Requirements:
* Develop relationships and mentor business users on QMS system requirements.
* Excellent written, oral, and interpersonal communication skills.
* Strong time management, communication, and organizational skills.
* Knowledge of quality and cGMP principles and systems, as well as relevant regulatory guidelines.
* Drive for results, dealing with ambiguity, learning on the job, and individual courage with a strong attention to detail.
* Project management skills with the ability to manage multiple tasks simultaneously.
* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Education and Experience:
A BS/BA in a scientific discipline is required. For Principal Quality Systems Specialist: at least 8 years of experience within Pharma or Biotech. Equivalent combination of education and experience will be considered. Senior Quality Systems Specialist: at least 5 years of experience within Pharma or Biotech. Equivalent combination of education and experience will be considered.