Position: Quality Assurance Assistant
Department: Quality Assurance
Immediate Supervisor: Quality Assurance Assistant Manager (or designee in their absence)
Job Outline
Duties
1. Administration of the Documentation Control System and the related files over their lifecycle
2. Maintenance of the Quality Management System (QMS) and the use of its associated software (Pragma and Adhoc)
3. Review of manufacturing and cleaning records
4. Review of shipment documentation and containers prior to release
5. Issuance of materials such as intermediates to production
6. Performance of the Good Manufacturing Practice (GMP) Walkthroughs as scheduled
7. Review of temperature and humidity data
8. Provision of proactive reporting and responses to quality related issues
9. Provision of assistance with the sourcing and preparation of quality documentation such as product quality reviews and with QMS processes such as change controls
10. Performance of cleaning visual inspections
11. Provision of training to others as required
12. Provision of assistance with audit preparation
13. General administrative duties for the Quality Assurance department
14. Performance of other duties as assigned by their supervisor (or designee in their absence)
Responsibilities
1. To adhere to cGMP and EHS practices at all times
2. To liaise with supervisors to ensure the rapid communication of issues and the progression of projects, documentation updates, etc.
3. To ensure the Documentation Control System is maintained and to ensure that documentation is updated as per change control and adherence to Good Documentation Practices, current revisions are issued and previous or obsolete revisions are archived, to ensure the archive and filing system is maintained as per best practice
4. To critically review manufacturing, cleaning and shipment documentation to ensure their adherence to cGMP and to address any outstanding issue prior to release
5. To assist other department members with quality documentation and QMS processes as required
6. To ensure the general administrative duties for the department are performed
7. To have a general interest in quality assurance activities and the desire for improvement opportunities
Working Conditions
This position is primarily an office-based role in the Quality Assurance Department with some duties performed within the GMP areas such as production, quality control and the warehouses.
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
The employee’s performance will be monitored by the Quality Assurance Assistant Manager and will be assessed as per the following criteria:
1. General timekeeping and attendance
2. Work output
3. Quality of workmanship
4. Compliance with agreed work schedule and programme
5. Compliance with Health, Safety and Environmental and Quality practices
6. Ability to work in a team environment
7. Ability to work independently
8. Work attitude
9. Training and self-development
10. Contribution to improving the department
11. Overall team performance
The Quality Assurance Assistant Manager shall hold Performance Reviews with the QA Assistant at periodic intervals to discuss performance, possible areas of improvement and set objectives.
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