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Validation Manager
לא צויןמשרה מלאהManufacturing Quality ManagementPharmaceutical Manufacturing
Lead and execute validation and calibration activities at a pharmaceutical manufacturing site, from planning through field execution, documentation, and final reporting.
תחומי אחריות
- Plan, perform, and approve validation of equipment, systems, and manufacturing processes, including IQ/OQ/PQ.
- Validate manufacturing and packaging equipment, utilities, cleanrooms, laboratory equipment, and computerized systems as applicable.
- Support equipment installation, FAT/SAT, and introduction of new equipment.
- Author validation protocols, reports, risk assessments, and SOPs; review and approve quality and validation documentation.
- Maintain and update the Validation Master Plan.
- Provide shop-floor support to production during changes, deviations, and troubleshooting; analyze processes, yields, and statistical data.
- Support technology transfer and new product introduction into commercial manufacturing.
- Manage validation and calibration contractors; coordinate with suppliers, service providers, and external laboratories and review their work.
- Manage validation-related deviations, investigations, CAPAs, and change controls.
- Prepare for and participate in regulatory inspections and internal audits.
דרישות
- Bachelor’s degree in engineering, life sciences, or a related field.
- At least 5 years of hands-on validation experience in a GMP environment.
- Direct experience performing validation activities, not solely managing them.
- Strong knowledge of GMP and pharmaceutical regulatory requirements and the full validation lifecycle.
- Experience with manufacturing equipment, utilities, and production systems.
- High-level English reading and writing skills; high-level Hebrew skills.