Job Description

###

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 Specialist. The successful incumbent will be required to:



To ensure excellence in the Quality Control departmental operations by leading technical initiatives and maintaining compliance with industry standards through:


Identifying, developing and validating new analytical methods relevant to NBI's product range, Qualification of QC laboratory equipment Investigating QC incidents and out-of-specification results, Monitoring performance of inhouse controls and reference standards, and applying statistical quality controls to identify adverse trends, Providing Laboratory Information Management System (LIMS) support, and Identifying and driving continuous improvement initiatives that align with cGMP requirements, regulatory standards, and industry best practice.
###

Minimum Requirements

Bachelor's science degree in Biochemistry, Chemistry, Analytical Chemistry or related field MSc. or PhD would be an advantage 5 years analytical laboratory experience of which 3 years laboratory supervisory experience At least 3 years method or equipment validation experience Computer literacy MS Office (Word, Excel, Power Point and Outlook) Project management experience Experience of using software such as Laboratory Information Management System (LIMS), SAP and Minitab is an added advantage Understanding of GLP / cGMP.
###

Duties and Responsibilities

Identify, validate and implement QC analytical methods and equipment/systems

Stay up to date by continuously researching relevant analytical methods and equipment to improve QC processes and systems. Identify, investigate and recommend relevant analytical methods and equipment to be considered for QC process improvements. Motivate for the consideration and approval of the method, instrument or process improvement. Draw up the relevant user requirement specifications. Prepare method validation and equipment qualification protocols in collaboration with NBI's Validation team, to guide and record the formal validation process, in line with cGMP, pharmacopoeial, scientific and regulatory requirements. Perform or coordinate the completion of the required activities in order to gather the required data for the validation process in collaboration with the relevant QC lab assistants and Validation team. Monitor and manage method validations progress and ensure validations are completed on time. Analyse the data and compile a statistically and scientifically sound validation report for review and approval. Prepare detailed SOPs on the method/equipment and train relevant QC staff on the new analytical method and/or equipment. Submit the required documentation to the Regulatory Team for processing and SAHPRA approval if needed. Ensure SAP change management are followed, and ensure that the new method or equipment is implemented into routine use after approval. Ensure the LIMS is updated accordingly as part of the implementation process of the change. Periodically evaluate the implementation to ensure optimal benefit and compliance with the objective.

Investigating QC incidents and out-of-specification results

Provide guidance to lab analysts in performing root cause investigation studies on out of trend and out of specification QC results, following NBI's procedure on OOS results. Evaluate results from the investigation and compile formal, scientifically sound reports for further evaluation by stakeholders such as QA. Share OOS report findings at OOS review meetings. Provide input into OOS results from in-process samples, to guide investigations by Manufacturing staff in the production processes. From time to time evaluate NBI's OOS and OOT SOP to ensure it is aligned with international best practice and latest regulatory requirements.

Monitoring and reporting performance of inhouse controls and reference standards

On a monthly basis, evaluate performance of inhouse controls and reference standards, using the LIMS reports and statistical tools. Prepare and submit to the QC manager a formal report on the performance of the controls and standards, based on the statistical review of the results. Prepare quarterly high-level summary reports on the performance of the standards and controls. Highlight and communicate any adverse trends as soon as they are identified. Provide guidance on establishing new inhouse controls, and sign off formal description of the new controls.

Routine reporting on QC results

Prepare monthly reports on QC laboratory processes, for the Process Control Review report on OOS results of raw materials, in-process samples, final products and utilities. Prepare and present a high level summary of QC lab operations and processes for the quarterly PCR meeting. Prepare and submit QC laboratory contributions to the annual product quality review report (APQR), using LIMS reports.

LIMS support

Provide support to LIMS administrator for QC related operations. Assist with LIMS tasks such as result authorisations and CoA generation as needed. Identify SAP QM and LIMS improvements and propose areas of improvement.

Technical and managerial lab support

Assist with trouble-shooting in case of problems with analytical methods and equipment. Liaise with suppliers and instrument engineers to resolve equipment issues in a timely manner. Assist the QC manager with special QC projects. Liaise with suppliers in order to achieve projects and operational objectives. Act as a back-up for QC Manager for assigned operational and management matters in his/her absence. Act as a back-up for Lead: QC Analyst for assigned duties in his/her absence. Attend meetings to represent QC and contribute in line with NBI business objectives as delegated.

Quality management, including continuous improvement

Up-hold quality standards and ensure cGMP/GLP is followed in the lab at all times. Ensure operational compliance by management of non-compliance through review of root cause analysis and implementation of required corrective action within agreed timeframes. Continuously review existing SOP's within the required timeframe, as required. Ensure appropriate maintenance of records and archiving of documents for easy retrieval. Identify opportunities for improvement in QC lab operations and analytical method performance, by considering audit findings, CAPAs, international best practice etc. * Attend meetings and training sessions as required, to remain informed of current field related developments and to promote knowledge sharing