QC Specialist

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 responsible for:

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.
• Applications are invited from suitably qualified and experienced candidates.
• Bachelor’s science degree in Biochemistry, Chemistry, Analytical Chemistry or related field
• M.Sc 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)
• Experience of using software such as Laboratory Information Management System (LIMS), SAP and Minitab is an added advantage
• Understanding of GLP / cGMP.

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…