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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.
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
- 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
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