QA & Document Controller Administrator

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 currently looking for 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.

* Co-ordinate 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.

 *Site Representative 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 to Site training Specialist as required 

* Adapt duties as needed based on changes in the group and its business.

• Proficiency in PC skills and intermediate level 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:

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