Key Performance Areas for this position include:
- Assist with all daily routine checks on all equipment eg. Temperature, pressure and any other potential compliance issues.
- To assist with all planned maintenance is completed by the agreed dates and manage the timelines with Section Head, where required.
- Aid in completing critical spares list
- To assist with setting up, plan and maintain maintenance programs for their building or department and site wide.
- To assist where needed with breakdown maintenance of all mechanical plant rooms, HVAC and utilities are completed
- Escorting service providers on site to conduct their maintenance/ work as and when required
- Ensure service providers adhere to cGMP and Bio-safety
- All documentation is completed correctly and according to cGMP requirements
- Ensure that the service provider complies with our legislative and cGMP requirement
- Assist in obtaining relevant certificates from providers where necessary
- All documentation is correct and filled in correctly per cGMP requirements and good document practice.
- Schedules completed as and when required, on time as agreed
- Assist Mechanical Technicians to draft and update relevant departmental SOP’s (Standard Operating Procedures) timeously
- Assist in the development in departmental procedures/systems in order to improve compliance.
- Building GMP Knowledge and Compliance
- Building Quality Culture
- Establishing and maintaining a state of Control
- Driving Innovation and Continuous Improvement
- Driving Quality Risk Management
- Ensuring that area of responsibility is audit ready; closing audit findings’
- Managing Deviations, Change Controls, CAPAs
- Quality Objectives: Drive the quality objectives.
- Ensure a timely and effective communication.
- Escalate quality issues to the appropriate levels of management
Technical Competencies
- Acquiring an understanding and working knowledge of Quality systems
- Acquiring knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and Laboratory Management
- Acquiring of pharmaceutical industry standards and guidelines in GMP, Quality and Laboratory Management
- Technical report writing
- Microsoft Excel for reporting
- cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO
- Quality management Systems
Generic Competencies
- Good coordination skills
- Attention to detail
- Record / documentation management
- Planning, implementation, execution and close out skills
- Service orientation
- Reporting and presentation capabilities
- Innovation and solutions orientation
- Flexibility and adaptability in responding to change