About the Role
Job Description:
The CAPA Specialist will report to the Quality Assurance Manager and be responsible for leading the Corrective and Preventative Action System (CAPA) across the facility. This includes conducting weekly or more frequent meetings to track timelines and quality of Quality Records (QRs) and associated actions.
The successful candidate will provide leadership and support on the CAPA process to all plant personnel, ensuring that all appropriate site Quality CAPA metrics are recorded and verified. They will also provide training to site subject matter experts and plant staff on CAPA requirements as guided by division/corporate policy.
The CAPA Specialist will review site QRs to ensure compliance to Rubric requirements and associated site and division policy requirements. They will collate CAPA information for site management review and area tier 3 information, and provide guidance in the management of unexpected manufacturing events, required bracketing and containment, and associated sampling if required.
This role will also involve supporting the QA CAPA IT System (ABTRAQ) through which investigations and CAPAs are documented, and liaising with other plant CAPA Specialists in Community of Practice meetings to address global concerns on CAPA opportunities/systems.
The ideal candidate will have a Diploma/Degree level education in science or engineering, with at least three years' experience in a quality assurance function within a regulated environment. Excellent interpersonal skills and very good computer literacy are essential, as is the ability to work effectively as a member of a high-performance team.
This role offers the opportunity to work in a dynamic and challenging environment, contributing to the success of our facility through effective CAPA management.
Key Responsibilities:
* Lead the CAPA process across the facility
* Conduct weekly or more frequent meetings to track timelines and quality of QRs and associated actions
* Provide leadership and support on the CAPA process to all plant personnel
* 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
* Support the QA CAPA IT System (ABTRAQ)
* Liaise with other plant CAPA Specialists in Community of Practice meetings
Requirements:
* Diploma/Degree level education in science or engineering
* At least three years' experience in a quality assurance function within a regulated environment
* Excellent interpersonal skills
* Very good computer literacy
* Ability to work effectively as a member of a high-performance team