Job Description
A QC Compliance Specialist is required by CareerWise Recruitment for our multinational biopharmaceutical client in Limerick for a full time onsite, initial 12-month contract role.
The QC Compliance Specialist will join a team responsible for Good Manufacturing Practice (GMP) quality compliance and audit readiness, within a manufacturing facility.
Role of this position
1. Manage and support projects and initiatives aimed at identifying opportunities for improvement in quality and compliance standards
2. Implementing, monitoring, maintaining, and improving the systems and processes used for Quality compliance.
3. Roll out of site quality initiatives.
4. Supporting departmental colleagues and partnering lines with guidance on documentation, compliance issues and systems support.
5. Working proactively to ensure delivery of on-time high quality records, investigations, and associated actions.
6. Monitoring metrics and trends to improve compliance standards that will meet internal and external auditor expectations.
7. Lead and support quality-based investigations and associated action outcomes, including on time completion.
8. Complete documentation updates associated with change requests, manufacturing, and cleaning to ensure compliance with global regulatory agencies and quality standards.
JOB REQUIREMENTS
9. A Bachelor's degree in science related subject (Micro/Chemistry/ Biochemistry or equivalent preferred).
10. 5+ years' relevant experience.
11. Good attention to detail and good documentation practices.
12. Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards (highly desirable).
13. Experience in quality management systems.