Job Description
We are currently looking for a QA & Document Controller Administrator to join our manufacturing site in Carrigtwohill, Cork. The candidate will provide Document Control services for the Cork site and administrative support to the QA Department, ensuring compliance with cGMP requirements and internal procedures.
Role & Responsibilities:
1. Manage Document Control for the Cork Site through the system, including support, training, and development.
2. Ensure issue, control, withdrawal, distribution, and destruction of controlled document copies across departments.
3. Coordinate periodic document reviews and file Master Copies.
4. Serve as the first point of contact during audits regarding Document Control queries.
5. Administer Documentum for the QA Department.
6. Issue and bind batch records for Production, manage archival both onsite and offsite.
7. Maintain QA Department files, archive systems, and office supply levels.
8. Prepare QA documents such as SOPs and Quality Agreements.
9. Print and maintain labels, prepare reports, documents, and presentations as needed.
10. Compile KPIs and information for Annual Product Reviews.
11. Act as Site Representative for the Documentation Center of Excellence (COE).
12. Assist QA Department preparations for Regulatory and Corporate Audits.
13. Participate in development and continuous improvement initiatives for QA and GMP compliance.
14. Support the Site training Specialist as required.
15. Adapt duties as needed based on changes in the group and its business.
Qualifications:
* Proficiency in PC skills and intermediate use of MS Office suite (Word, Excel, Outlook, PowerPoint).
* Experience using an EDMS computerized solution is essential.
* Excellent verbal and written communication skills.
* Leaving Certificate minimum; Science-related degree preferred.
Additional Information:
AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, and serving our community. We welcome applications from all qualified individuals.
For more information, visit AbbVie's Equal Opportunity Employer page.
Applicants seeking reasonable accommodations can learn more at this link.
#J-18808-Ljbffr