Job Description We are looking for a QA/QP to join our team on our Cork site.
As QA/QP you will contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.
This will be an opportunity for someone to work within QA whilst pursuing a QP position with us through training and registration onto our QP license. Responsibilities will include: 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. Internal Auditing when required, of FLI Departments and external auditing when required, of Material and Service Suppliers (including Supplier Management). You will be involved in reporting and communicating to the QA Operations Manager in case of detection of a discrepancy / non-compliance and by assisting in the preparation and reviewing of QA department reports and metrics. Participate in the development of the quality standard across the site by being involved in initiatives and action plans for the development of QA and improvement of GMP compliance.
This might also include, participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients You will also be involved in assisting in preparation and presentation of GMP training programmes. Assist in New Product Introduction Activities when required. As QA/QP you are involved in release of products by reviewing all documentation associated with batch release to ensure GMP compliance, verifying the labelling of the raw material, packaging components, bulk and finished product, ensuring the follow-up of the necessary corrective actions & preventative actions implemented in consequence of a quality failure and by performing investigations, and ensuring a follow-up, following discrepancy, failures and external complaints. The QA/QP will review all documentation associated with batch release to ensure GMP compliance. Qualifications Bachelor degree in a relevant area Education to meet the requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16. Minimum 3 years pharmaceutical experience in a regulated environment. Previous management/supervisory experience an advantage Knowledge of GMP.
Good organisation and presentation skills and time management. 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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