QA Document Controller & Training Admin

Company Description 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. Job Description We are looking for a QA Document Controller & Training Admin for manufacturing site in Carrigtwohill , Co Cork. To provide a Document Control Service and maintenance of the company’s Training Program. These services are to meet the requirements of in-house procedures and to be executed in compliance with cGMP requirements.

• The support and development / assistance (training and support guides) of Document Control system
• Issue, control, withdrawal, distribution and destruction of controlled copies of documents for quality department
• Co-ordination of Periodic Document Reviews.
• Filing of Master Copies of Documents.
• Problem resolution for Document Control system
• Site contact for global SOPs updates
• Ensuring that all that above are in compliance with cGMP, global and local procedures and are in a continuous state of audit readiness.
• Administration for the QA Department
• Issuing and binding of batch records for Production.
• Maintain files and archive systems in the QA Department.
• Ensure office supplies are on hand to meet demand.
• Withdrawal, distribution and destruction of controlled QA documents.
• Maintain the system for issuing, reviewing and archiving of QA logbooks.
• Preparation of QA documents such as SOPs and Quality Agreements etc.
• To prepare reports, documents, presentations etc. as required.
• Compilation of KPIs.
• COE document lead
• Manage, maintain, and update an efficient LMS
• Provide support to and deputise for Site training Co-Ordinator
• Implement corrective actions of retraining due to non-compliance to procedures
• Assist with the creation of training related memos, if required
• Assist in preparation of QA Department for Regulatory and Corporate Audits
• Work Cross Functionally and Independantly as required to drive continuous improvement

Qualifications

• Experience of using an EDMS computerised solution is essential
• Good PC skills and intermediate level use of MS office is essential (Word, Excel, Outlook & PowerPoint)
• Previous experience in the pharmaceutical industry
• The person should be a highly organised, self-starter capable of working as part of a team or on their own initiative

Additional Information 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