Quality Coordinator - PHARMACEUTICAL MANUFACTURING

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

• Business Skills:

• Basic Mechanical knowledge
• Knowledge of regulations and compliance (GMP, SAHPRA, WHO, FDA, etc.)

• 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.

• 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.

• Non-compliance with safety regulations can lead to significant legal and financial consequences, including fines and operational disruptions.

1. LEVEL OF DECISION MAKING

• Moderate to Minimal, with significant decisions related to validation requiring higher-level approvals.