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You will be updated with latest job alerts via emailWe 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.
* 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.
*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.
Qualifications :
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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Full-time