Validation Manager

Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.

About The Job

• Manage and ensure implementation of validation work activities and relevant validation documentation including facility equipment, manufacturing process, cleaning, and computer system validation as well as bulk holding time studies in Cairo site.
  
  

Responsibilities

• Accountable for all validation activities in the site and responsible for implementation of validation life cycle.
• Prepare and update site validation master plan (VMP) for Cairo site, stating the scope, rationales, and Schedules.
• Accountable for validation working parties for planning and coordinating the different validation activities and deliverables related to new systems, facilities, equipment, processes, or products.
• Ensure conducting all validation activities as per Al Jamjoom QMS requirements.
• Follow up and ensure that required validation documentation DR/IQ/OQ/PQ protocols, reports, interim reports, and validation summary reports are prepared and approved for new or upgraded machines and analytical equipment.
• Ensure cleaning, process validation and Media fill programs are being implemented based on scheduled plan.
• Ensure effective implementation of validation review practices for scheduled utilities, Equipment, and computerized systems.
• Ensure effective implementation of validation review on products and cleaning processes as per QMS requirements.
• Endorse completion of all validation work required for change control requests up to their final closure.
• Approve training curricula for department representatives and ensure curricula is relevant to job description.
• Identify validation related risks and ensure adequate management of corresponding mitigation plans.
• Responsible for technical and personal development of direct reports by using effective appraisal, performance management and implementing training for validation organization.
• Present validation updates and KPIs for quality councils and performance management.
  
  

Qualifications

• University graduate pharmacy or relevant.
• 10 years of experience in the pharmaceutical industry.
• Good knowledge ofc GMP, GLP safety regulation and EDA regulatory guidelines.
• Good technical experience in analytical testing with its related aspects.
• Excellent Knowledge of English language
• Good communication skills.