QA Supervisor (QMS/IPQA)

Main Duties:

• Preparation and revision of Site Master File and Quality Manual.
• Revision/ Preparation of SOPs & materials and finished products specifications, art works & batch production records and controlling the required changes for master documents.
• Reviewing of batch records, ensuring that the relevant tests are carried out and ensuring that finished products are suitable for its intended use before releasing to the market.
• Investigation of batches failure, procedures & processes deviation and complaints,determination the root causes for non-conformity, issuing an investigation report contain the required corrective/preventive actions and ensuring that corrective/preventive actions are implemented.
• Responsible for Handling of CRN, incidents, deviation reports, CAPA and failure investigation in the plant.
• Co-ordination of recalls, issuing a recall report contain the required actions and ensuring that actions are implemented.
• Monitoring the implementation and compliance with Good Manufacturing Practice principles through conducting periodical self-inspection, issuing an auditing report contain the required actions and ensuring that actions are implemented.
• Monitoring training plans, providing training for all the personnel whose duties take them into production areas or into control laboratories and for other personnel whose activities could affect the quality of the product.
• Ensuring the products quality review at defined intervals, evaluation for the results of the review and issuing an assessment report contain the required or recommended action.
• Evaluation of the processes through performing statistical analysis and process control including control charts, FMEA, Pareto charts… etc. and applying the concept of lean manufacturing.