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 TikTok.
Job DescriptionWe are currently looking for a QA & Document Controller Administrator to join our manufacturing site in Carrigtwohill, Cork. The candidate will provide a Document Control Service for the Cork Site and an Administration Service to the QA Department, ensuring compliance with cGMP requirements and internal procedures.
Role & Responsibilities:- Manage Document Control for the Cork Site through the system, including support, training, and development.
- Ensure issue, control, withdrawal, distribution, and destruction of controlled document copies across departments.
- Coordinate the periodic document reviews and file Master Copies.
- Serve as the first point of contact during audits regarding Document Control queries.
- Administer Documentum for QA Department.
- Issue and bind batch records for Production, manage archival both onsite and offsite.
- Maintain QA Department files, archive systems, and office supply levels.
- Prepare QA documents such as SOPs and Quality Agreements.
- Print and maintain labels, prepare reports, documents, and presentations as needed.
- Compile KPIs and information for Annual Product Reviews.
- Represent the site for Documentation COE.
- Assist QA Department preparations for Regulatory and Corporate Audits.
- Participate in development and continuous improvement initiatives for QA and GMP compliance.
- Support the Site training Specialist as required.
- Adapt duties as needed based on changes in the group and its business.
- Proficiency in PC skills and intermediate use of MS Office suite (Word, Excel, Outlook & PowerPoint).
- Experience using an EDMS computerised solution is essential.
- Excellent verbal and written communication skills.
- Leaving Certificate minimum; Science-related degree preferred.
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 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
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