Job Description We are now hiring a Sr Quality Specialist to join our team in Manorhamilton Road, Sligo for a fixed term contract of 23-months.
This person will coordinate the development and maintenance of company's quality system in compliance with all applicable regulatory requirements and ensure that products manufactured at AbbVie meet requirements of end users, of regulatory authorities and of the company.
This is an opportunity for someone to take on a key role on our NPI and early -stage commercial site of choice within our network and continue to build on the strong quality culture that we are so proud of in AbbVie. Responsibilities: Documenting and establishing a quality system which ensures full compliance with all regulatory and AbbVie requirements. Ensuring all plant personnel are fully aware of quality and cGMP requirements. Initiation and Completion of Quality related ERs as required. Establishing Corrective / Preventive Action system and procedures. Verification of effectiveness of corrective / preventive actions arising out of product, process and quality system non-compliance. Supporting all aspects inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books. This position is crucial in identifying any causes of non-compliance of the quality system while maintaining effective communication with all employees within the plant and external auditors. Liaison with AbbVie International Quality Assurance, FDA, HPRA and other regulatory bodies. Implementation review for Policy documents. Supporting all NPI activities on site from a quality perspective, liaising closely with Technical Operations, Manufacturing and Laboratory functions. Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings e.g.
SPM. Coordination of product quality review activities. Coordination and management of all track and trend activities to support manufacturing and QC. Coordination and facilitation of all site RCS and FMEA activities. Auditing the quality system with other management personnel. Assisting in the investigation of and coordinating customer complaints/exceptions by ensuring implementation of effective corrective / preventive action where necessary. Providing quality guidance, support and approval on all site/system validation activities. Coordinating change control and Change plan activities. Monitoring quality performance and advising management personnel on major quality issues. Management of Supplier Performance metrics and audit schedules as well as vendor and supplier evaluation and approval where applicable. This position will assist in ensuring that the causes of deviations and nonconformances are identified and eliminated. Responsibility for direct reports. Qualifications Third level qualification in a science, quality or relevant discipline. A minimum of 3 years' experience in a quality role. A strong knowledge of regulatory requirements is required. 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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