**Job Summary:**
We are seeking a Quality Specialist to join our team. The successful candidate will be responsible for reviewing quality records, providing leadership and direction on corrective and preventative action systems, and ensuring compliance with relevant regulations.
Key Responsibilities:
* Conduct weekly or more frequent CAPA meetings to track timelines and quality of quality records and associated actions.
* Provide leadership and support on the Corrective and Preventative Action System to all plant personnel.
* Ensure that all appropriate site quality CAPA metrics are recorded and verified.
* Report on monthly metrics with regard to CAPA and QRs.
* Provide training to site subject matter experts and plant with regard to CAPA requirements as guided by division/corporate where required.
* Review site QRs to ensure compliance to Rubric requirements and associated site and division policy requirements.
* Collate CAPA information for site management review and area tier 3 information.
* Provide guidance in management of unexpected manufacturing events, required bracketing and containment and associated sampling if required.
* Complete Global CAPA review for impact to Cootehill site and support elevation process for site issues as required post QR approval.
* Support the QA CAPA IT System through which investigations and CAPAs are documented.
Requirements:
* A Diploma/Degree level education – science/engineering qualification with at least three years of manufacturing experience in a quality assurance function within a regulated environment.
Benefits:
This role offers a dynamic work environment, opportunities for professional growth and development, and a competitive compensation package.
About Us:
We are a global leader in healthcare, committed to improving people's lives through innovative solutions and technologies.