Validation Co-ordinator; Cleaning Validation, Process Validation and Continuous Process Verification Specialist

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Job Purpose:
To plan, coordinate, and execute all validation operational requirements within the Validation Department including Process Validation (PV), Cleaning Validation (CV), Continuous Process Verification (CPV), equipment qualification, and supporting lifecycle activities according to SAHPRA, PIC/S, ISO, and Validation procedures including AICC Quality system processes remain validated, controlled, and Audit inspection ready.

Key Job Outputs:

Process Validation

• Compiling and execute Process Validation protocols
• Evaluate and identify critical process parameters (CPPs) and critical quality attributes (CQAs)
• Selection of validation approach (traditional vs lifecycle, bracketing, matrixing)
• Analyse batch data to confirm process capability
• Recommend process improvements where variability is detected
• Generate final reports process validation reports
• Provide technical justification for validation decisions

Cleaning Validation

• Define residue limits using toxicological and dosage-based calculations
• Select appropriate sampling methods (swab/rinse) based on risk
• Selection of validation approach (traditional vs lifecycle, bracketing, matrixing)
• Evaluate recovery studies and analytical capability
• Ensure cleaning procedures are robust and repeatable
• Provide technical justification for validation decisions

Continuous Process Verification (CPV)

• Develop CPV plans and statistical models
• Create and maintain trending tools using batch data
• Statistical evaluation of process capability
• Establish alert and action limits
• Investigate adverse trends and recommend corrective actions
• Provide technical justification for validation decisions

Qualification & Lifecycle Activities

• Support equipment and utility qualification where required
• Facilitate risk assessments (e.g., FMEA)
• Conduct periodic reviews and determine revalidation requirements
• Compile, execute and write reports for qualifications, periodic review and re-qualification