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AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube and LinkedIn.
Pharmaceutical Research & Development
AbbVie pharmaceuticals combines advanced science with expertise to make strides in drug and treatment discovery, making a remarkable impact on people's lives
We are current looking for a QA Specialist for a 12 month FTC to join our diverse Quality department at our Manufacturing site in Carrigtwohill, Co Cork
Role & Responsibilities
GMP documentation
Reviewing the GMP documentation e.g., SOPs, reports, methods, specifications, validation protocols, quality contracts etc., and Exceptional Documents e.g., NCRs/PNCRs, Planned Deviations etc.
Writing and reviewing QA department procedures and reports e.g., protocols, SOPs, environmental reports etc. Reviewing and approving other departmental procedures and reports.
Auditing and investigations systems
Auditing systems:
Internal Auditing (when required) of FLI Departments and external auditing (when required) of Material and Service Suppliers (including Supplier Management).
By alerting the QA Compliance Manager in case of detection of a discrepancy / non-compliance.
Change control activities
Participation in change control activities on site.
Reporting and communication
By assisting in the preparation and reviewing of QA department reports and metrics e.g., monthly quality report, discrepancy reports, exceptions reports, KPI reports.
By reporting and communication to QA Compliance Manager on key events and issues etc. via normal in-house reporting structure e.g., meetings, formal reports etc.
Participate in the development of the quality standard across the site.
Participate in initiatives and action plans for the development of QA and improvement of GMP compliance.
Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients.
Assist in preparation and presentation of GMP training programmes.
Represent QA on Business Excellence projects to ensure compliance to GMP.
Meet the quality standards.
Ensure QA activities are executed in line with in-house procedures and in compliance with requirements of cGMP.
SAP
SAP Local Key User for the QA Department
Supplier Management
Support supplier activities (qualification, risk management and notification management) are executed in line with in-house and Abbvie Global Procedures and in compliance with requirements of cGMP.
New Product Introduction
Assist in New Product Introduction Activities when required.
Contribute to the quality assessment of clinical, pre-commercial product, and IMPs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
