QA Specialist

We are looking for a QA Specialist to join our Quality Assurance team in Cork on a Fixed Term Contract until September 2027.

As a QA Specialist you will be responsible for providing quality assurance support for quality system requirements associated with: pharmaceutical products medical devices combination products and biologics. Specific areas of support may include Storage and Distribution Product Complaints potential quality events/product shortage execution Supplier Controls Product Quality Review Risk Management Agency inspections/internal audits CAPA and overall Quality Manual requirements. This position will ensure that all product process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate governmental and local regulations and requirements.

Responsibilities:

• Assist with the integration and support of quality regulations: drug biologics device and/or combination products.
• Assist in the design of effective quality systems procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. Evaluate analyze and trend quality indicators data and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective.
• Partner coordinate and support activities related to product actions in the affiliate.
• Assist project teams in planning preparation review and approval of quality documentation. Coordinate the Management Review process for the affiliate.
• Perform assessments to determine compliance to processes procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting response to observations and tracking of action plans.
• Participate in training and education programs for various aspects of quality assurance.
• Coordinate and investigate quality events such as deviations non conformance product complaints and corresponding action plans including decisions.
• Quality management of supplier qualification program including performance monitoring for key suppliers.
• Ensure metrics and KPIs are being met. Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
• Represent affiliate QA in regional global and cross functional teams projects and programs as assigned by management.

Qualifications :

• Bachelors Degree in Chemistry Pharmacy Biology Microbiology Engineering or other technical/scientific area preferred.
• 3 years experience in quality assurance quality oversight or relevant experience.
• Technical knowledge in as many of the following areas as possible: Quality Regulatory Process Sciences Manufacturing Operations.
• Knowledge and familiarity with product process and both internal and external customer requirements.
• Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device biologics and pharmaceutical products preferred.
• Strong oral and written communication skills needed.
• Strong computer skills and knowledge of enterprise systems such as SolTraqs EBR & SAP.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time