PE Global are currently recruiting for a QA Specialist – required for 9 month maternity FTC for a Chemicals Manufacturing client site in Portlaoise:
Duties and Responsibilities
Responsible for leading the quality processes and product validation processes for product commercialization
Responsible for evaluating new and current processes to determine validation/verification requirements
Responsible for risk assessing new/current processes
Responsible for ensuring adequate controls are in place to ensure product quality and reduce risk of non-conforming product
Responsible for managing project related non-conformances’ and providing support to all other departments in relation to investigation of issues identified as part of projects.
Responsible for managing and supporting project related CAPA’s
Responsible for providing QA decisions for Product Commercialization Process.
Responsible for updating/creating/review and approval of validation protocols and reports
Responsible for meeting agreed timelines for product commercialization
Responsible for reviewing packaging specifications ensuring product contact packaging meets customer, regulatory and compatibility requirements. (i.e., leachable, extractables)
Responsible for label management for new products
A key member of the product commercialization
Responsible for providing regular project updates to management
Responsible for escalating QA concerns/issues/challenges to QA Manager
Qualifications (Education, Certification, Experience)
Bachelor’s Degree in a Science Related Discipline preferred
Trained internal auditor is an advantage
1 -3 years previous experience in a similar role
1-3 years’ experience in a regulated environment Competency Assessment
Good knowledge of current regulatory requirements
Working knowledge of ISO 9001:2015 is required, EXCiPACT and IPEC regulations an advantage.
Experience working with a paper-based quality management system
Strong attention to detail, focused on delivery of a Quality product.
Good organizational skills with the ability to prioritize, demonstrate agility and adjust well to changes.
Strong interpersonal and communication skills, ability to maintain a positive, Quality focused relation with internal and external stakeholders.
Strong problem solving and conflict resolution skills
Demonstrate Company core values of agility, collaboration, commitment, discipline, honesty, innovation, integrity, open to change
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