Published Description:
CAPA Engineer – Kelso, Scotland
Leads the overall CAPA (Corrective and Preventive Action) process at the site, ensuring effective, timely, compliant execution of CAPA, by providing appropriate level of oversight whilst driving innovation and continual improvement.
Key Job Accountabilities:
• Coordinate and Facilitate site level CAPA review Board
• Train identified CAPA users in the CAPA process
• Coach trained users in best practices and the use of appropriate problem solving tools to develop CAPA skill set at the site
• Provide practical expertise and technical guidance in development and execution verification of effectiveness plans, ensuring objective
evidence of effectiveness prior to CAPA closure
• Drive accountability for timely completion of records to ensure sustainable achievement of quality and compliance metric targets
• Ensure all CAPA records are complete, compliant to good documentation practices (GDP) and include appropriate objective evidence
• Support CAPA approval process and ensure all appropriate approvers are included in each CAPA
• Escalate issues and roadblocks that are preventing progress and success
• Develop, implement and report out trend analysis of CAPA
• Provide data and SME input in to the site Quality System Management Review, Metric Dashboard and Operations reviews as appropriate
Additional Accountabilities:
• Perform assigned site and regional internal audits, supporting the development of the internal audit program
• Support external registration or agency audits and Regulatory Inspections.
• Assist in developing and sustaining quality documents within the Document Control System (DCS).
• Participate in corporate projects.
• Occasional travel may be required to meet the needs of the business (estimated 10% to 20%).
• Additional duties as assigned.
Education/Experience Qualifications:
• A minimum of a Bachelor’s degree is required
• Experience of using Quality Systems Tools is required
• Strong working knowledge of Regulatory and Standard requirements for CAPA is required
• Experience with Problem solving methodologies is required; Lean six sigma certification is preferred
• Internal Audit experience is required; internal audit certification is preferred
• An equivalent combination of education and experience sufficient to successfully perform the key job accountabilities may be considered.
Other Qualifications:
• Employee must be self-motivated with the ability to work independently and in a team environment.
• Employee must be experienced in giving training both in classroom setting and in 1:1 on the job environment
• Good oral and written communication skills are necessary.
• Attention to detail and computer literacy are essential.
• Project Management knowledge is advantageous.
• General office equipment and materials.