· Prepare Documents for analytical staff including SOPs for process, Instrumentation, Validations, Change controls, Deviations, CAPA.
· Help with laboratory investigations, CAPA assessments and effectiveness checks.
· Assist with periodic review of documents and Test Methods.
· Support Internal Audits and Regulatory Audits of analytical functions.
· Assist with instrument and software qualification.
Aid in the management of training for the analytical labs.
Coordinate Training (30%) – Support the coordination and implementation of electronic learning management systems as well as paper-based training systems, to ensure training requirements are in place and met by the analytical labs.
Document Control (30%) – Assist in creation, reviews and revisions of reports, protocols, test methods and SOPs both in electronic systems and in paper based systems. Provide advice on Data Integrity, SOP writing, good documentation practices, auditing analytical laboratories, software qualification, identifying compliance gaps
Support Analytical Staff (40%) – Prepare and review Quality System Documents for analytical staff including SOPs for process and Instrumentation, Validations, Change controls, Deviations, CAPA. Aid annual audits ensure SOPs are followed and cGMP compliance is being practiced. Assist in the creation of metrics, presentations and reports to showcase to management on compliance matters.