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Job Details
AbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Join AbbVie's Quality Assurance team as an MQA Lead at our Biologics facility in Ballytivnan, Sligo. You will play a key role in ensuring that our marketed and investigational drug products meet global standards, providing quality oversight and guidance for aseptic manufacturing operations in a highly regulated environment.
Responsibilities
- Ensure all products meet requirements for patients, regulatory authorities, and the company.
- Provide quality and compliance oversight to operations, supporting aseptic production and intervention observation.
- Lead investigations into product or manufacturing process non-compliance issues.
- Guide, train, and support shift team members in decision-making.
- Review and audit batch records, manufacturing logs, and operational SOPs.
- Perform line clearance, raw material checks, and maintain product status as required.
- Lead GEMBAs of manufacturing areas and drive continuous improvement.
- Act as SME for quality issues during shift operations.
- Uphold all cGMP, HPRA/FDA, and EHS standards.
- Third-level degree in science, quality, or engineering.
- Minimum 3 years' experience in quality/operations in a GMP-regulated environment (biologics preferred).
- Experience in aseptic processing highly desirable.
- Excellent written/verbal communication and interpersonal skills.
- Demonstrated experience in regulatory inspections
- Proven knowledge of regulatory requirements and strong problem-solving, communication, and interpersonal skills.
- Previous experience as a trainer
- Commitment to quality, attention to detail, and Right First Time ethos
- Previous leadership experience
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.
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