Job Description We are recruiting a part time QA Compliance Specialist to join our team at AbbVie 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 AbbVie 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 AbbVie 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.
Qualifications 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.
Additional Information 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 - to learn more, visit US Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: