Cgxp Administrator

**BASIC JOB FUNCTIONS (Brief Summary)**:

- Manage, maintain & improve regulatory compliance for computerized systems.
- Co-ordination of support activities relating to validation
- Knowledge of regulations governing pharmaceutical manufacturing (API)
- Maintaining maintenance contracts and managing software renewals
- Collation of GxP reports /statistics
- Testing of data restore capability (Business continuity)
- Liaising with end-user w.r.t end-user requirements (Capex and departmental requirements)
- Basic active directory management across various networks
- Inventory /Asset management
- Change control management
- cGxP documentation pertaining to various systems
- Adherence to system review procedures
- Software/Hardware Repairs
- Monitor and maintain system upgrade /patch management
- Install and configure new computers and other IT equipment related to the laboratory
- Repair and upgrade the different types of systems (software and hardware)
- Printer, scanner, and copier repairs
- Manage users’ groups
- Liaise and manage vendor callouts /call logging
- Ad hoc IT-related requests
- Assist staff with IT-related issues when called upon
- Carry out other duties as may be requested by management
- Standby where required

**PERSONAL ATTRIBUTES (Brief Summary)**:

- Must be organized hands-on, disciplined, punctual, honest, and have sober habits
- Effective communication with staff at all levels of the business
- Have an eye for detail and accuracy
- Requires an infallible ability to work well under pressure
- Strong customer service orientation
- Ability to translate IT terminology into the user-friendly terminology

**JOB REQUIREMENTS**:

- Minimum Grade 12 or equivalent as per NQF framework
- A+ or N+ certification or 1-3 years in a similar role
- Experience with Laboratory systems & 21 CFR part 11 (Chromatography etc.)
- Good communication skills telephonically/written
- SAP administration (added advantage)
- Auditing: Added advantage