QC Method Validation Lead, LIMS & cGMP Expert

NBISA Recruitment; Durban; On-site; ZAR 350,000 - 550,000; Full time

Job summary

National Bioproducts Institute NPC in Durban seeks a QC Specialist to lead QC analytical method development and validation, ensuring cGMP/GLP compliance. You will guide method and equipment qualification, manage OOS investigations, and coordinate LIMS/SAP enhancements with the Validation and QA teams.

You will mentor staff, prepare SOPs, and drive continuous improvement while maintaining rigorous documentation for regulatory review and product quality.

Qualifications

• 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 LIMS, SAP and Minitab is an added advantage.
• Understanding of GLP / cGMP.

Responsibilities

• Identify, validate and implement QC analytical methods and equipment/systems.
• Stay up to date by researching relevant analytical methods and equipment to improve QC processes.
• Identify, investigate and recommend analytical methods and equipment for QC improvements.
• Motivate for method, instrument or process approval and draw up user requirement specs.
• Prepare method validation and equipment qualification protocols with Validation team.
• Monitor validation progress and compile validation reports for review.
• Prepare SOPs on methods/equipment and train QC staff.
• Submit documentation to Regulatory Team and ensure SAP/LIMS changes are implemented.
• Periodically evaluate implementation for compliance and benefit.

Skills

Laboratory leadership

Analytical method development

Statistical analysis

Quality systems knowledge

Problem solving

Education

Bachelor’s degree in Biochemistry/ Chemistry/ Analytical Chemistry or related field

MSc or PhD would be an advantage

Tools

LIMS

SAP

Minitab

Microsoft Office

Job description

National Bioproducts Institute NPC in Durban seeks a QC Specialist to lead QC analytical method development and validation, ensuring cGMP/GLP compliance. You will guide method and equipment qualification, manage OOS investigations, and coordinate LIMS/SAP enhancements with the Validation and QA teams.

You will mentor staff, prepare SOPs, and drive continuous improvement while maintaining rigorous documentation for regulatory review and product quality.