Job Title
QA & Document Controller Administrator
We are seeking a highly organized and detail-oriented QA & Document Controller Administrator to join our team at our manufacturing site in Carrigtwohill, Cork.
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.
Qualifications
* 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.
About Us
AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, and serving our community. We value diversity and inclusion and are proud to be an Equal Opportunity Employer/Veterans/Disabled.