Validation Coordinator
Permanent @Adcock Ingram posted 1 week ago in Healthcare & Medical Shortlist Email JobJob Detail
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Job ID 10857
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Experience Level: 3 Years
Job Description
We are looking for a Validation Co-ordinator who will plan, coordinate, and execute validation activities—including PV, CV, CPV, and equipment qualification—while ensuring compliance with SAHPRA, PIC/S, ISO, and internal procedures to maintain controlled, validated, and inspection-ready systems.
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
Job Requirements
- Tertiary qualification in Science or Engineering (e.g. BSc Science, National Diploma in Science/Engineering, or equivalent)
- Computer literacy certification (ICDL or equivalent demonstrated competence) will be an added advantage
- Project Management qualification or proven project management experience in a cGMP environment will be an added advantage
- Demonstrated continuous improvement mindset (e.g. Lean, Six Sigma exposure or practical application) will be an added advantage
- Minimum of 3 years’ experience in a pharmaceutical process or manufacturing environment, preferably:
- Filling and packing operations, or
- Plastics extrusion or similar regulated manufacturing processes
- Practical, on-the-job experience in:
- Validation activities (qualification, validation, process validation, continued process verification, cleaning validation, revalidation, requalification)
- Quality Assurance and/or Quality Control
- Exposure to cGMP-regulated operations is essential
- Demonstrated ability to interpret process flows, specifications, and operational data
- Strong written and verbal communication skills suitable for technical documentation and cross-functional engagement
- English – proficient in reading, writing, and verbal communication
Required Skills
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