KEY RESPONSIBILITIES

Product release

• Assist with any/all documentation relating to product release and the accurate capturing of records and data.
• Assist with the control and storage of release samples.
• Perform Lot release checks according to prescribed procedures to ensure GMP compliance.
• Assist with Data Logger handling and temperature monitoring activities.

Operational activities:

• Assist with delivery of day-to day Quality Assurance activities, ensuring adherence to plans and schedules.
• Assist with the accurate completion of all database entries, registers and forms.
• Assist with the compilations and/or reviews of departmental SOP’s.
• Assist with recording of CAPA’s, deviations and any other reports.
• Assist with quality related investigations.
• Assist with recording and arranging destructions as and when required.
• Liaise with suppliers as and when required.
• To carry out any other administrative duty as and when required
• Assist with annual reviews per product including but not limited to report preparation, sample inspections and supplier requests.
• Assist with tracking, communication, and support of annual QA plan activities.
• Assist with review of laboratory and/or stability results.

Good Manufacturing practice (GMP)

• Maintain all GMP principles in line with departmental Quality System and SAHPRA requirements.

Training

·       Attend and/or present training sessions as and when required

Requirements

PRE-REQUISITES

• Bachelor of Science