Quality Operations Director - Saudi Arabia

دوام كامل في a Laimoon Verified Company في Saudi Arabia

نُشرت يوم January 13, 2025

تفاصيل الوظيفة

A leading pharmaceutical company.Responsibilities:Develop, implement, manage and integrate an effective QMS (Quality Management System) meeting all requirements of cGMP and drug laws where applicable.Establish and implement Quality metrics (process capability, change control, non-conformances/deviation, etc.) monitoring and reporting system and ensure its effectiveness to make sound and appropriate Quality decisions.Establish effective strategies, quality systems, and procedures to assure appropriate compliance with all GMP/GLP directives.Establish a comprehensive Quality review process (PQR) as per latest pharmacopoeia/regulatory requirements, considering all aspects including pre/post analysis data of commercially marketed products. Identify gaps and improvements in each PQR of the product.Develop and implement management review process based on participation of top management to review the Quality management system, at planned intervals to ensure its suitability, adequacy, and effectiveness. This review shall include assessing opportunities for improvement and the need for changes including the Quality objectives. At least 2 Management review meetings shall be conducted in a calendar year.Ensure all product-related market complaints are addressed with appropriate investigation and CAPA (Corrective and Preventive Action) within the specified time frame. Acknowledgement and reply about investigation/action taken must also be sent to all complainants including hospitals/institutions, doctors, distributors, etc.Design, implement, and document procedures for process control, process improvement, testing, and inspection for material receiving to final release of products.Help manage Quality control procedures on a day-to-day basis and serve as the primary quality control resource for problem identification, resolution, and continuous improvement.Monitor vendor performance and establish a system for vendor qualification and approval based on vendor facility audit considering the nature of materials used.Review/report Quality issues/problems and trends about existing/potential non-conformance to the Managing Director.Manage and conduct audits and inspections of internal and external vendors, TPM/trial sites, or other facilities to ensure adherence with the Quality Management System requirements.Ensure all Quality agreements are done as per basic requirements of the Quality management system and cGMP.Develop and implement an effective CAPA system and ensure root-cause analysis and other problem-solving activities as per recommended corrective/preventive actions.Ensure the system of internal Quality audits considering all functional areas that impact product Quality based on material receiving to final release of products and also at distribution levels.Review customer purchase orders, contracts, and change requests and ensure that the necessary criteria and provisions are included in the Quality management system.Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel.Review/give feedback on suppliers' purchase orders and establish supplier quality requirements.Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.Support the site by participating in design development projects representing Quality assurance and the customer.Establish and allocate Quality Assurance resources from the assigned functional group to support all appropriate objectives. Provide detailed information to the Functional Planner, Project Planners, and other functional groups regarding the progress of Quality Operations.Manage to achieve the Quality Operations goals/objectives.Manage to achieve management review process of the site at least twice a year.Manage to achieve Performance Appraisals of Quality Operations employees on an annual basis.Represent the Quality Operations activities in OPCOM forum and discuss/share all important/significant issues which have Quality impact.Minimum Requirements:Experience in designing, implementing/strengthening Quality management systems of an organization.Broad knowledge, expertise, and skill demonstrating experience to improve the pharmaceutical process and its control.A PhD degree in chemistry.Excellent communication skills (written and verbal).Strong computer skills including quality control applications, word processing, spreadsheets, and databases.Thorough knowledge/understanding of cGMP and general safety requirements.Training in Quality Management system, CAPA & Investigation, and Quality metrics/trend reporting and management review process.Good experience of audit/inspection of the site based on internal and external audits.

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