you will be responsible for:Validation Lifecycle OwnershipLead end-to-end Computer System Validation (CSV) and Computer System Assurance (CSA) activities for GMP-critical systems, including validation planning, protocol development, execution oversight, report approval, and lifecycle management. Ensure systems are validated, maintained, and remain audit-ready throughout their lifecycle.Risk-Based ValidationApply risk-based validation principles to determine appropriate validation strategies, deliverables, and testing approaches based on system GxP classification, business criticality, and regulatory impact.
Lead and facilitate system and functional risk assessments to define validation scope, testing requirements, and compliance controls.Validation Documentation & Compliance EvidenceEnsure validation deliverables, records, evidence packages, system histories, compliance documentation, and deliverable registries are complete, traceable, maintained, and aligned with applicable procedures and regulatory expectations.Knowledge Transfer & Transition SupportEnsure validation documentation, compliance records, and system histories are properly captured and transitioned during system handovers, organizational changes, and service transitions to maintain continuity of the validated state.Qualifications & Experience Bachelor's degree or equivalent in Computer Science, Software Engineering, Information Systems, Life Sciences, Engineering, or a related discipline.
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Monitor and analyze quality system performance, identifying opportunities for improvement and implementing corrective and preventive actions.
Drive continuous improvement initiatives using quality tools and methodologies to enhance product quality, process capability, and operational efficiency.
Ensure effective management of non-conformities, root cause analysis, and corrective action processes.
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• Ensure the feasibility of the required blowing test according to the instructions received in written form, in the case of oral information (after-sales service), they must be validated in return by the customer.
• Manage the blowing test schedule and FAT preparation and warns her/his manager in case of delay
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Develops and establishes quality systems and procedures, inspection plans, quality performance trends, statistical plans, control plan, cost estimates and technical quality plans for proposals;
Ensures that project and/or process control documentation is compliant with requirements and/or contract;
Proposes enhancements and improvements to products and processes by applying continuous improvement and key lean manufacturing/production principles and techniques to critical areas of production;
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Ensure adherence to established data governance policies and business rules, advocating for their importance among team members and business users
Guide and support business users through changes in data management processes, data policies, and/or business rules to ensure smooth transitions and minimal disruption
Request, approve and/or oversee data maintenance requests, ensuring they align with data policies and business rules
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Record and compile laboratory analysis results (physical and electronic) on a daily basis for review and verification by the superior.
Conduct all laboratory testing in accordance with approved Standard Operating Procedures (SOPs).
Monitor and manage laboratory inventory, including chemicals, reagents, equipment, testing media, and spare parts, and report status to the supervisor.
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Improvement & Training: Actively seek ways to improve process efficiency and product quality. Educate and train plant staff on proper quality control procedures to ensure site-wide compliance.
Improvement & Training: Actively seek ways to improve process efficiency and product quality. Educate and train plant staff on proper quality control procedures to ensure site-wide compliance.