Qc Lims Specialist

**Job Advert Summary**:
Guided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBI’s vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products.

National Bioproducts Institute NPC has a vacancy for the role of QC LIMS Specialist. The successful incumbent will be required to:
To drive operational excellence in the Quality Control function through effective management of the Laboratory Information Management System (LIMS), ensuring compliance with industry standards through:

- Designing and implementing optimal LIMS configurations to automate and streamline laboratory processes.
- Identifying, developing and performing user acceptance testing of new modules or modifications to existing modules in LIMS to maximise its utility at NBI.
- Managing system maintenance, troubleshooting, and integration with SAP.
- Investigating LIMS and SAP-related incidents and implement opportunities for improvement.
- Monitoring and reporting on performance of LIMS processes.
- Keeping up to date with the latest developments on QC LIMS.

**Minimum Requirements**:

- Bachelor’s science degree in Biochemistry, Chemistry, Analytical Chemistry or related field
- MSc would be an advantage
- 3 years analytical or pharmaceutical QC laboratory experience
- At least 3 years demonstrable LIMS experience
- Broader experience with QC laboratory computerised systems, SAP and analytical software would be added advantage.
- Computer literacy MS Office (Word, Excel, Power Point and Outlook)
- Project management experience
- Understanding of GLP / cGMP

**Duties and Responsibilities**:
**Day to day LIMS support**
- LIMS super user / administrator for all QC related operations.
- Design and testing of LIMS inspection plans and implementation for new materials or modifications to existing materials.
- Ensuring the LIMS is up to date, by implementing authorised changes in LIMS and SAP QM relating to new materials, changes in analytical methods, specifications etc.
- Setting up and maintaining LIMS stability templates.
- Optimal setup of all LIMS modules to support QC operations, in line with best practices.
- Performing housekeeping tasks on LIMS such as adding or deleting user profiles, managing samples and authorising results.
- Maintaining SAP QM and LIMS in relation to other SAP modules.
- Setting up custom reporting templates to facilitate quick and easy reporting of QC results.
- Issuing CoAs for API’s and final products, for sign-off by the QC manager.
- Managing the tie-in of analytical equipment into LIMS for seamless data transfer by identifying suitable equipment, liaising with the external service provider and performing user acceptance testing.
- Setting up of the LIMS reference sample module to manage the QC reference sample program.
- Liaising with the IT department to update SAP QM and LIMS as it relates to QC related processes.
- Troubleshooting in case of problems with LIMS and SAP inspection plans, result reporting, etc.
- Liaising with the LIMS consultant to resolve issues in a timely manner.
- Attending training sessions, user forums etc as required, to remain informed of current related developments and best practices, and to promote knowledge sharing.

**Routine reporting on LIMS performance**
- Setting up, running and analysing SAP QM and LIMS reports in line with the QC system.
- Preparing and presenting high level summaries of QC lab operations and processes for monthly and quarterly reports.
- Preparing and submitting QC laboratory contributions to the annual product quality review report (APQR), using LIMS reports.

**QC operational support**
- Identifying QC operations that can be automated and supported using LIMS.
- Assisting QC analysts, the Lead QC analyst and QC Specialist by providing statistical analyses, including linear regression, of routine QC and stability study data using the LIMS SQC module.
- Assisting the QC manager with special QC projects relating to LIMS.
- Assisting with troubleshooting in case of problems with analytical methods and equipment.
- Acting as a back-up for Lead: QC Analyst for assigned duties such as results authorisations in his/her absence.
- Attending meetings to represent QC and contribute in line with NBI business objectives as delegated.

**Production of utilities**
- Manages the production of WFI, HPW and steam
- Manages supply of raw water for production and entire plant
- Manages and ensures, operation and maintenance of cleanroom HVAC system
- Ensures continued supply of clean compressed air
- Manages electrical supply for the entire plant and backup power system.

**Quality management, including continuous improvement**
- Identifying SAP QM and LIMS improvements and proposing areas of improvement, by considering audit findings, CAPAs, international best practice etc.
- Up-holding quality standards and ensuring LIMS complies with cGMP/GLP requirements