Job Title: QA Specialist - 9 Months Fixed Term Contract (Maternity Cover)
Department: Quality Assurance
Reporting to: QA Manager
Location: Portlaoise, Ireland
Greenfield is looking for a Quality Assurance Specialist to join our growing team to support the Product Commercialisation (ProdCom) function, ensuring new products are successfully validated, compliant, and delivered to market in line with regulatory and customer requirements.
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 CAPAs
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)
Internal auditing experience advantageous
1-3 years previous experience in a QA role within a regulated environment (e.g., GMP, ISO)
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, respect and responsibility in all activities
Greenfield Global is an equal opportunities employer. We are committed to fostering an inclusive workplace where diversity of thought, background, and experience is valued and respected.
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