AbbVie Senior Compliance Specialist (12 Month Fixed Term Contract) in Sligo, Ireland

Senior Compliance Specialist (12 Month Fixed Term Contract)

Ireland, Connaught, Sligo

Research & Development

Requisition #1804792

Here at AbbVie , based on Manorhamilton Road, Sligo, we have dedicated capabilities for potent active pharmaceutical ingredient and drug product manufacturing. This site recently underwent a significant €85 million expansion that doubled its footprint and provided additional capability to support AbbVie’s new product introductions.

We focus on innovative new technologies and with our high performing team; we develop and deliver products and processes to support AbbVie’s wider global needs. We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well. Choose AbbVie if you share our passion for improving the health and lives of patients.

To learn more about AbbVie in Ireland, please click on www.abbvie.ie or at http://www.abbvie.ie or/ check us out on https://www.youtube.com/user/AbbVie

We are currently sourcing a high calibre Senior Compliance Specialist to join our Quality team in Sligo on a contract basis. The successful candidate will be responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and AbbVie requirements.

Key Responsibilities:

  • Coordinating the quality system, ensuring full compliance by all personnel with its requirements.

  • Coordination of Product Quality Reviews activities.

  • Management of all Technical Agreements from initiation, review, approval and storage.

  • Coordination and Management of all Track and Trend activities to supportManufacturing 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 .

  • Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings e.g. SPM.

  • Coordinating change control and Change plan activities.

  • Liaison with AbbVie International Quality Assurance, FDA, HPRA and other regulatory bodies.

  • Regulatory review.

  • Initiation and Completion of Quality related ER’s 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.

  • Vendor evaluation and approval.

  • Supplier related Notifications and evaluations.

  • Management of Supplier Performance metrics.

  • Management of Supplier Audit Schedule.

  • Performance of Vendor audits as required.

  • Implementation review for Policy documents.

  • Performing and managing housekeeping audits to ensure that they are scheduled, executed and closed on time.

  • Supporting all aspects inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books.

  • Third level Degree in Science, Quality (or relevant discipline)

  • People Management experience is desirable