Quality Control Specialist

SUMMARY:
Our client's vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products.  Already longstanding in the market, they are enjoying growth and expansion.

POSITION INFO:
Purpose of the Role:
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 product range,
• Qualification of QC laboratory equipment.
• Investigating QC incidents and out-of-specification results.
• Monitoring performance of in-house controls and reference standards, and applying statistical quality controls to identify adverse trends.
• Providing Laboratory Information Management System support.
• Identifying and driving continuous improvement initiatives that align with cGMP requirements, regulatory standards, and industry best practice.

• Bachelor’s Degree in Biochemistry, Chemistry, Analytical Chemistry or related field.
• M.Sc or PhD, a strong advantage.
• Minimum 5 years analytical laboratory experience essential.
• Minimum 3 years laboratory supervisory experience.
• At least 3 years method or equipment validation experience.
• Project management experience.
• Understanding of GLP / cGMP.
• Experience using software such as Laboratory Information Management System (LIMS), SAP and Minitab, an added advantage.

• Identify, validate and implement QC analytical methods and equipment/systems:
  • Continuous research to improve QC processes and systems.
  • Identify, investigate and recommend relevant analytical methods and equipment.
  • Prepare method validation and equipment qualification protocols and manage progress.
  • Compile statistically and scientifically sound validation reports.
  • 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 the LIMS is updated accordingly as part of the implementation process of SAP change management.
  • Periodically evaluate the implementation to ensure optimal benefit and compliance with the objective.
• Investigate QC incidents and out-of-specification results and provide guidance to Lab Analysts on out of trend and out of specification QC:
  • Evaluate results and compile scientifically sound reports.
• Monitoring and reporting performance of in-house controls and reference standards to the QC Manager, using the LIMS reports and statistical tools.
• Prepare monthly reports on QC laboratory processes on a monthly basis, 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 quarterly meetings.
• Prepare and submit QC laboratory contributions to the annual product quality review report (APQR), using LIMS reports.
• Provide support to LIMS Administrator for QC related operations and propose areas of improvement.
• Technical and managerial lab support:
  • Liaise with suppliers and Instrument Engineers to resolve equipment issues.
  • Assist the QC Manager with special QC projects.
  • Act as a back-up for QC Manager and Lead: QC Analyst.
  • Attend meetings to represent QC and contribute in line with business objectives as delegated.
• Quality management, including Continuous improvement:
  • Identify opportunities for improvement in QC lab operations and analytical method performance, by considering audit findings, CAPAs, international best practice, etc.

• Leading and influencing others.
• Managing relationships.
• Personal leadership.
• Business impact.
• Attention to detail and analysis.
• Planning and organising.
• Technical/professional knowledge and proficiency.
• Technical writing skills.
• Good verbal and written communication skills.
• Teamwork.
• Quality orientation and awareness.