Job Description 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.
Qualifications Educated to third level in science-based discipline. Degree level preferable.
Minimum 3 years pharmaceutical experience in a regulated environment would be preferable.
Experience in pharmaceutical environment a significant advantage.
Knowledge of GMP. Good organisation skills and time management.
Analytical approach to problem solving.
Additional Information 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.
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