Maintain working knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR).
Perform incoming inspection and release of raw materials.
Perform batch record review on finished products and manage process.
Prepare customer documentation packages.
Manage record archiving
Understand and interpret relevant EP and USP monographs to ensure specifications are kept up to date and changes processed as required.
Prepare monthly indicators for review by QA Supervisor as required.
Maintain and control documented Change Control system.
Participates on the Internal Quality Audit team.
Utilise the Trackwise system for non conformances, deviations, Corrective and Preventative actions (CAPA).
Prepare new SOPs and edit/delete revised SOPs.
Provide training and support to other QA staff as required.
May be required to perform other related duties as required and/or assigned.