Quality Assurance Specialist Role
">
We are seeking a Quality Assurance Specialist to join our team in Cavan on a permanent contract.
The Quality Assurance Specialist will be responsible for ensuring that quality records are completed and leadership and direction for QR initiation and root cause are complete.
About the Role:
This role involves ensuring that monthly metrics are recorded and reported out as required. The impact of ineffective reporting may have implications for plant operations and compliance requirements.
Key Responsibilities:
* Conduct weekly or more frequent CAPA meetings to track timelines and quality of quality records (QRs) 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 SMEs with regard to CAPA requirements as guided by the division/corporate, where required.
* Review site QRs to ensure compliance with Rubric requirements and associated site and division policy requirements.
* Collate CAPA information for site management review and area tier 3 information.
* Guide management of unexpected manufacturing events, required bracketing and containment and associated sampling if required.
* Complete global CAPA review for impact to the site and support elevation process for site issues as required post QR approval.
* Support the QA CAPA IT System (ABTRAQ) through which investigations and CAPAs are documented. This also involves the development and support of plant SME's and general users.
* Liaise with other plant CAPA specialists in community of practice meetings to address global concerns on CAPA opportunities/systems.
* Food safety team member – actively participating in food safety team meetings, as required.
* Participate in internal audits and compliance walkdowns.
Requirements:
* A degree in science/engineering.
* 3+ years manufacturing experience in a quality assurance function within a regulated environment.
* Excellent interpersonal skills and very good computer literacy.
* Ability to work as an effective member of a high performance team.