Description:
QUALIFICATION AND EXPERIENCEMatric 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.) 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.
13 Mar 2025;
from:
gumtree.co.za