Industry : Pharmaceutical
The QA Specialist is a key part of the Quality team ensuring the site has a strong operational compliance
focus which is aligned with the principles and expectations of the current Good Manufacturing Practice
(cGMP) regulations. This role will ensure that the manufacturing team has direct and effective support to
ensure manufacturing of products meets Right First Time expectations while maintaining a high standard
of continuing compliance and process improvement.
Essential Duties, Functions and Responsibilities:
Review of batch record paperwork on the manufacturing shop floor and to manage of the control of SOPs and associated documents.
Perform detailed batch record review of finished products prior to / for QP release.
Assist in the completion of Customer Quality Complaint investigations as they relate to manufacturing.
Quality Assurance oversight of in-process quality inspection within manufacturing/packaging.
Participates as required in training program development and implementation.
Notifies manager of compliance questions and issues.
Strong attention to detail and precision in preparing, reviewing and issuing GxP documentation.
Experience in batch record review and process improvement.
Very strong written and verbal communication skills.
Experience in a sterile product GMP manufacturing environment and familiarity with the associated technologies and quality processes.
Proficiency with Microsoft Word, Excel, PowerPoint, Visio and ideally an electronic document system.
Ability to interpret technical procedures, SOP’s, GMP’s and applicable regulations and provide advice and guidance as required.
Role Skills/Knowledge Desirable:
Experience working with: QMS Systems, Trackwise, Veeva.
Experience in participation in GMP Regulatory body audits e.g. FDA, HPRA or equivalent.
Degree in a Science related discipline.
2+ years’ experience working in QA in a Sterile Product GMP Environment
Work Environment/Hazards and Physical Demands:
There is a moderate physical demand in this role due to the nature of entry manufacturing.