SUMMARY:
The primary function of a Quality & Validation Coordinator the Safety, Health and Environment Coordinator (SHE Coordinator) is to implement and maintain the Quality Assurance program of the plant. The secondary function of the Quality & Validation Coordinator is to lead and maintain and implement the validation program of the plant.
POSITION INFO:
QUALIFICATION AND EXPERIENCE
- Matric
- Diploma in a Quality or Science field (Analytical Chemistry, Biotechnology, Microbiology, or equivalent)
- Microsoft Office proficiency
- Basic Mechanical knowledge
- Knowledge of regulations and compliance (GMP, SAHPRA, WHO, FDA, etc.)
Quality Management - Administer and maintain non-conformance and quality management systems, including Corrective and Preventative Action (CAPA), Non-conformance Report (NCR), change control and deviations.
- Ensure quality requirements are met by both internal and external audit, review of inspection reports and analysis of non-conformance reporting.
- Assist in vendor/contractor performance monitoring and ensure only appropriate vendors/contractors are utilized.
- Ensure quality plans are produced when required and meet regulatory requirements.
- Monitor and maintain internal quality standards.
- Assist with CAPA close -out for self-inspections.
- Assit with training material and training record.
- Document and maintain Quality records..
- Other quality-related duties as assigned by the Line- Manager.
Validation Lead Responsibilities (20%)- Develop and maintain the Validation Master Plan (VMP).
- Lead and execute validation activities for processes, equipment, utilities, and cleaning validation.
- Develop and review validation protocols (IQ, OQ, PQ) and reports.
- Conduct risk assessments related to validation and ensure all validation activities are compliant with regulatory requirements.
- Ensure requalification and periodic validation review of critical systems and processes.
- Coordinate validation activities with production, engineering, and quality teams.
- Address deviations, CAPAs, and change control related to validation.
- Maintain validation documentation in compliance with regulatory expectations.
- Support audits and inspections by providing validation documentation and evidence.
Impact of Errors- Non-compliance with safety regulations can lead to significant legal and financial consequences, including fines and operational disruptions.
- LEVEL OF DECISION MAKING
- Moderate to Minimal, with significant decisions related to validation requiring higher-level approvals.
