Job Description
AbbVie Ballytivnan is recruiting for a QA Compliance Specialist. The position reports to the Quality Systems Manager and is responsible for documenting and establishing a quality system that ensures full compliance with all regulatory and AbbVie requirements. The QA Compliance Specialist also assesses and reports on the effectiveness of the quality system to senior management.
Responsibilities
Coordinating the quality system and ensuring full compliance by all personnel.
Coordinating Product Quality Review activities.
Managing all Technical Agreements from initiation, review, approval and storage.
Coordinating and managing Track and Trend activities to support Manufacturing and QC, driving a QRM approach on site.
Facilitating all Site RCS and FMEA activities.
Auditing the quality system per the internal audit schedule.
Assisting in documenting, investigating, and coordinating customer complaints and exceptions, and implementing effective corrective/preventive actions.
Ensuring products manufactured at AbbVie Biologics Ballytivnan meet requirements of end users, regulatory authorities, and the company.
Measuring performance of the quality system and reporting at management review meetings and quality performance meetings.
Coordinating change management, change control, and change planning activities; monitoring quality performance and advising management personnel on major quality issues.
Liaising with AbbVie Global Quality Assurance, FDA, HPRA, and other regulatory bodies for regulatory review.
Initiating and completing quality-related investigations and verifying the effectiveness of CAPAs.
Establishing and maintaining corrective/preventive action systems and procedures.
Managing the supplier program including ASL, performance metrics, and audit schedules.
Creating and approving commodity specifications.
Performing vendor audits and supporting all aspects of inspection readiness, including preparation activities, logistics, and generation of follow-up responses and proof books.
Qualifications
Tertiary qualification in a science, quality, or engineering discipline.
Minimum 3 years’ experience in a similar role in a pharmaceutical or sterile manufacturing environment.
Strong knowledge of regulatory requirements.
Excellent written and verbal communication skills with strong attention to detail.
Equal Opportunity Employer
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving its community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only. For more information on equal employment opportunity: https://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlFor reasonable accommodations: https://www.abbvie.com/join-us/reasonable-accommodations.html
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