Quality System Specialist
Maintains site compliance of operations in accordance with mandated regulatory requirements and site expectations.
Key Responsibilities:
* Ensures compliance with all aspects of quality for the Raheen site, including manufacturing, quality systems, quality control, validation, facilities, and materials management.
* Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
* Collaborates with cross-functional teams to resolve issues, complete investigations, and maintain compliance.
* Responsible for QA reviewing and approving documents such as Failure Investigations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOP's), GxP documents, and Change Control documents.
* Reviews system records for assignment, compliance, and closure.
* Provides administrative support of electronic systems.
* Reviews procedures, policies, and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
* Monitors and reports on trending metrics associated with site quality systems.
* Actively participates in continuous improvement initiatives, initiating and implementing changes.
Requirements:
* Bachelor's degree in a scientific discipline.
* 8 years of experience in Pharma or Biotech for Principal Quality Systems Specialist role.
* 5 years of experience in Pharma or Biotech for Senior Quality Systems Specialist role.