Sr. Quality Compliance Specialist
Limerick
A leading global biotech company is looking for a Sr Quality Compliance Specialist to join their team.
Duties:
This role participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.
- Responsible for ensuring compliance with all aspects of Quality in manufacturing, quality systems, quality control, validation and facilities.
- 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 review and approval of failure investigations, CAPA's, SOP's, GxP documents, Change control documents
- Lead & support investigations
- Review procedures, policies and other instructional documents relating to quality systems
- Provision of monitoring and trending metrics associated with site quality systems.
- Actively participate in continuous improvement ideas, initiation, and implementation.
- Participation in internal, regulatory and customer audits.
- Train personnel on quality system processes.
Requirements:
BS/BA in scientific discipline or related field
5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry.
Relevant experience may be substituted for education requirement.
For more information or to apply email [email protected]
