We are recruiting a part time QA Compliance Specialist to join our team at Abb Vie Manorhamilton Road, Sligo. The QA Compliance Specialist is responsible for maintaining and improving the site quality system to ensure full compliance with GMP, HPRA/FDA and Abb Vie quality requirements. The role includes assessing the effectiveness of the quality system and reporting outcomes to senior management. This role is a 6 month role.

Key responsibilities

• Own and maintain the site quality system, ensuring compliance with regulatory and Abb Vie requirements.
• Lead and support regulatory inspections and requests, including preparation, logistics and responses.
• Support Quality Risk Management(RCS, FMEA) and internal GMP audits.
• Initiate and close out quality events/records (ERs) and drive resolution of quality system non‑compliances.
• Provide QA and validation support, including review/approval of validation and change controls.
• Monitor and report quality system performance at management and quality review meetings.
• Ensure site personnel understand and follow quality, cGMP and policy requirements.
• Adhere to and promote EHS & E standards.

Decision making and scope

• Make risk‑based, compliant decisions on change controls, validation and policy implementation.

• Manage day‑to‑day compliance queries and escalate significant issues as required.

• Influence product quality and manufacturing performance through effective quality system oversight.

• Third‑level qualification in a Science or Quality discipline.

• Minimum 3 years’ experience in a pharmaceutical or sterile manufacturing environment.

• Strong knowledge of GMP, quality systems and regulatory expectations (HPRA/FDA).

• Strong written and verbal communication skills.

Abb Vie 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 - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.