Job Description
The Quality System Specialist plays a crucial role in ensuring site compliance with regulatory requirements and company expectations.
Key Responsibilities:
* Ensure compliance with quality aspects for the Raheen site, including manufacturing, quality systems, quality control, validation, facilities, and materials management.
* Maintain regulatory compliance according to current Good Manufacturing Practices (cGMP).
* Collaborate with cross-functional teams to resolve issues, complete investigations, and maintain compliance.
* Review and approve documents such as Failure Investigations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOP's), GxP documents, and Change Control documents.
* Review system records for assignment, compliance, and closure.
* Provide administrative support of electronic systems.
* Review procedures, policies, and instructional documents related to quality systems to ensure compliance with company policy and local and international regulatory requirements.
* Monitor and report on trending metrics associated with site quality systems.
* Participate in continuous improvement initiatives, initiate, and implement changes.
* Participate in internal, regulatory, and customer audits.
* Train personnel on quality system processes.
* Supervise team members.
Requirements
* Demonstrate ability to develop relationships and mentor business users on QMS system requirements.
* Excellent written, oral, and interpersonal communication skills with ability to interact with diverse audiences.
* Excellent time management, communication, and organizational skills with proven track record of multi-tasking.
* Knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.
* Drive for results, dealing with ambiguity, learning on the job, and individual courage with strong attention to detail.
* Project management skills with ability to manage diverse tasks simultaneously.
* Effective coordination and management of work responsibilities under general guidance.
* Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Education and Experience
Bachelor's degree in scientific discipline required. For Principal Quality Systems Specialist: minimum 8 years experience in Pharma or Biotech. Equivalent combination of education and experience will be considered. Senior Quality Systems Specialist: requires minimum 5 years experience in Pharma or Biotech. Equivalent combination of education and experience will be considered.