Join to apply for the QA Compliance Specialist (Part-time) role at AbbVie
Company Description
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address tomorrow's medical challenges. We strive to impact people's lives across key therapeutic areas – immunology, oncology, neuroscience, and eye care – and in our Allergan Aesthetics portfolio. For more information, visit www.abbvie.com. Follow AbbVie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.
Job Description
More than a job – it's a chance to make a real difference
We are recruiting for a Part-time QA Compliance Specialist on a Fixed Term contract based in AbbVie Manorhamilton, Sligo.
The QA Compliance Specialist is responsible for documenting and establishing a quality system that ensures full compliance with all regulatory and AbbVie requirements. The role includes assessing and reporting on the effectiveness of the quality system to senior management.
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 support Manufacturing and QC.
* Driving a QRM approach to all activities on site.
* Coordination and facilitation of all Site RCS and FMEA activities; auditing the quality system per the documented internal audit schedule.
* Assisting in the documentation, investigation, and coordinating customer complaints/exceptions by ensuring implementation of effective CAPA where necessary.
* Ensuring that products manufactured at AbbVie meet requirements of end users, regulatory authorities, and the company.
* Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings.
* Coordinating change management, change control, and change planning activities.
* Monitoring quality performance and advising management personnel on major quality issues.
* Initiation and completion of quality-related investigations and verification of the effectiveness of CAPA as required.
* Establishing Corrective/Preventive Action system and procedures; managing the Supplier program including the ASL, performance metrics, and audit schedules.
* Creation and approval of commodity specifications as required; performance of vendor audits as required.
* Supporting all aspects of inspection readiness, including preparation activities, logistics, and generation of follow-up responses and management of proof books.
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Adhering to and supporting all EHS & E standards, procedures, and policies.
Qualifications
o Third-level qualification in a science or quality discipline.
o Minimum 3 years' experience in a pharmaceutical or sterile manufacturing environment.
o Experience with internal and external auditing.
o Strong written and verbal communication skills.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer, Veterans, Disabled.
US & Puerto Rico only – for more information, visit equal employment opportunity page.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more.
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