Ref. no.: MK/34480/IJP
Tags: CAPA & Metrics Specialist CAPA & Metrics Specialist Longford
Location(s): Longford
Salary range (€): Negotiable
Additional benefits:
Minimum experience required: 1 - 2 Years
Employment type: Permanent Full-time
Minimum qualification: Third Level Degree
Contact person: Michelle Kilcar
Contact e-mail: michelle@ccprecruit.ie
Job description: CAPA & Metrics Specialist The successful candidate will be responsible for compiling and analyzing site metrics and maintaining an effective CAPA system in compliance with Division and external regulatory requirements. The successful candidate will also be involved in continually improving site compliance. Major Responsibilities: • Maintain and update an efficient metrics reporting and CAPA system.• Develop plant wide knowledge to ensure appropriate analysis of non conformances.• Actively support ER reduction and compliance improvement initiatives.• Assist in identifying and driving key compliance improvement projects to completion.• Carry out analysis of data to identify adverse trends and systemic issues.(Using DMAIC problem solving tools)• Tracking and trending of ERs (i.e. NCRs, PNCRs, Deviations and LIRs)• Tracking of relevant Quality Metrics parameters in support of the CAPA system.• Providing Quality Metrics Analyses and Reports to Quality and Site Management.• Maintenance of respective Quality records and reports.• Provide training and subsequent support to site users of GQMS (Global Quality Management System)• Timely compilation of analyses and respective reports.• Confirm, review and approve actions in the nonconformance system.• Benchmark sister sites compliance activities Skills/Experience Requirements • Third Level Diploma or Degree in natural sciences, biotech, quality engineering or a relevant discipline.• A minimum of 1 years experience in a regulated environment is desirable.• An excellent knowledge of Microsoft Office especially Excel is required for this role.• Experience in generation, reporting and publishing of metric related reports is desirable• Excellent Presentation & Communication skills are essential.• The ability to work co-operatively and effectively with others to establish and maintain good working relationships.• Technical knowledge to assist with investigations and appropriate CAPA assignment would be advantageous.• Self Starter who can drive for results and meet or beat deadlines• Excellent attention to detail. Education Requirements • Third Level Diploma or Degree in natural sciences, biotech, quality engineering or a relevant discipline.