Quality Assurance Assistant
This role is primarily an office-based position in the Quality Assurance Department with some duties performed within GMP areas such as production, quality control, and warehouses.
Duties:
* Administration of the Documentation Control System and maintenance of the Quality Management System (QMS) and its associated software.
* Review of manufacturing and cleaning records, shipment documentation, and containers prior to release.
* Issuance of materials such as intermediates to production and performance of Good Manufacturing Practice (GMP) Walkthroughs as scheduled.
* Review of temperature and humidity data, provision of proactive reporting and responses to quality-related issues.
* Assistance with sourcing and preparation of quality documentation and QMS processes, performance of cleaning visual inspections.
* Provision of training to others as required and assistance with audit preparation.
* General administrative duties for the Quality Assurance department and other duties as assigned by their supervisor.
Responsibilities:
* To adhere to cGMP and EHS practices at all times and liaise with supervisors to ensure rapid communication of issues and progression of projects.
* To maintain the Documentation Control System and update documentation according to change control and Good Documentation Practices.
* To critically review manufacturing, cleaning, and shipment documentation to ensure adherence to cGMP and address any outstanding issues prior to release.
* To assist other department members with quality documentation and QMS processes as required.
* To ensure general administrative duties for the department are performed and have a general interest in quality assurance activities and desire for improvement opportunities.
Working Conditions:
The company will provide workplace conditions in which its personnel can function safely and efficiently. All personnel are required to comply with current standard operating procedures and cGMP as required.
Work Performance:
* Performance will be monitored by the Quality Assurance Assistant Manager and assessed based on the following criteria: timekeeping and attendance, work output, quality of workmanship, compliance with agreed work schedule and programme, Health, Safety and Environmental and Quality practices.
* Able to work in a team environment, work independently, display a good work attitude, participate in training and self-development, contribute to improving the department, and demonstrate overall team performance.