QA Operations Compliance Specialist

About the role

AbbVie is seeking a QA Operations Compliance Specialist to join its Biologics site in Ballytivnan, Sligo. The role ensures that all products leaving the facility meet the stringent standards required for marketed and investigational drug products, supporting both regulatory compliance and patient safety.

Key responsibilities

• Verify that all released products comply with regulatory, company, and end‑user requirements.
• Provide quality and compliance oversight to the Operations function, ensuring adherence to site policies and procedures.
• Lead or assist investigations arising from product or process non‑compliance.
• Review and audit completed batch records and manufacturing logs.
• Conduct quality reviews of operational documentation such as SOPs, JSTMs, and risk assessments.
• Perform incoming raw material checks and maintain product status.
• Support stability programs, including sample pulls, weekly checks, and protocol generation.
• Administer quality logs (e.g., QA Hold, Sample Request) and conduct daily floor walk‑arounds.
• Drive continuous improvement initiatives to simplify processes while maintaining compliance.

Required profile

• 3rd‑level qualification in a relevant science discipline.
• Minimum of 3 years experience in a comparable quality role.
• Pharma or regulated GMP background is essential.
• Ability to work independently and meet tight deadlines.

Required skills

• Good Manufacturing Practice (GMP) knowledge.
• Quality assurance and regulatory compliance expertise.
• Batch record review and audit experience.
• Familiarity with SOPs, risk assessments, and stability testing procedures.

What we offer

• Opportunity to work within a global, research‑driven biopharmaceutical company.
• Collaborative environment focused on innovation and patient impact.