Job Description This position, reporting to QA Supervisor, will support the QA Process Support team based in AbbVie North Dublin.
Their primary focus will be to enhance and maintain the cGMP standards systems on the Clonshaugh site.
This position will primarily be involved in supporting and coordinating day-to-day activities in the Production Department at AND.
Primary duties and responsibilities of the position are as follows; other duties may be assigned.
· Performs room release and batch sign in for manufacturing operations.
· Carries out and monitor established QA/GMP programmes.
· Carries of Environmental Monitoring and associated trending.
· Gives assistance in the retain system for samples and documents.
· Carries out Batch Manufacturing Review and review of batch related documents.
· Provides assistance in departmental and regulatory audits.
· Carries out QA inspection of starting and packaging materials, in-process and finished materials.
· Carries out sampling of starting and packaging materials, in-process and finished materials.
· Has the ability to train a colleague in a particular GMP procedure or related activity.
· Author SOPs, logbooks, forms, and other documentation, as required.
Track and publish review schedules.
Follow-up with reviewers and approvers to assure review schedules are met.
· Initiate, facilitate, monitor, trend Change Control, CAPAs and other Quality System documents as required.
· Carry out and assist in the on-going training of new and existing personnel, as appropriate.
· Perform routine review of documentation generated by personnel such as BMRs, logbooks, forms, protocols, reports, COAs, etc. generated to support commercial and development products for accuracy, completeness, and compliance to GMP and procedural requirements Qualifications A third level qualification in a scientific discipline, preferably a B.Sc.
/M.Sc.
Preferably, at least two years pharmaceutical experience with good working knowledge of cGMP Strong knowledge of FDA/EMEA regulatory requirements.
Excellent organisational, communication and interpersonal skills.
Ability to set and maintain the highest standards.
· Available for shift work as required Proficiency in using Microsoft Office 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 US Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: