Senior QA Manufacturing Compliance Specialist
AbbVie View all jobs
- Sligo
- Permanent
- Part-time
- Ensure all products and process simulations meet standards for market/investigational use.
- Provide quality guidance and compliance oversight throughout manufacturing.
- Lead or support investigations related to non-compliance in product or processes.
- Mentor, train, and provide support to shift team members.
- Audit batch documentation, review logs, and process SOPs.
- Support and execute line clearance, raw material checks, and stability program activities.
- Manage and maintain finished product status, labeling, and quality logs.
- Conduct daily manufacturing area walkarounds and seek process improvements.
- Support quality aspects of MVI, AQL, and NPI process/material handovers.
- Maintain compliance with cGMP, HPRA/FDA, EHS, and AbbVie standards.
- Third-level degree in science, quality, or engineering.
- Minimum 3 years' experience in a GMP quality/operations setting (biologics preferred).
- Strong experience in aseptic processing and advanced knowledge of regulatory requirements.
- Excellent written/verbal communication and interpersonal skills.
- Experience as a trainer preferred.
- Demonstrated commitment to quality, problem-solving, and continuous improvement.
Recruitireland