Senior Validation Analyst

Description

Job Summary: Professional to perform process, equipment, and system qualification and validation, developing and managing documentation and tests. Key Highlights: 1. Thermal qualification and validation of processes and systems. 2. Development and management of validation documentation and tests. 3. Participation in projects and management of validation activities. **Job Description** --------------------- • Perform activities related to Thermal Qualification, Equipment Qualification, Thermal Box Qualification, Process Validation, and Computerized System Validation; • Develop Validation Documents related to the activities described above, such as Protocols, Plans, Risk Assessments, and Reports; • Analyze Validation Deviations and propose corrective actions; • Execute Thermal Qualification, Operational Equipment Qualification, and Process Validation tests; • Discuss results of conducted studies, prepare indicators, trend reports, and other applicable analyses; • Manage execution of tests performed by third-party companies, where applicable; • Manage Qualification/Validation activities, ensuring adherence to deadlines; • Manage Calibration activities; • Calibrate instruments; • Develop and manage Change Controls; • Develop CAPAs, conduct investigations, and propose actions; • Manage Validation Documentation within the Quality Management System; • Deliver training on validation procedures and work instructions; • Participate in projects.**Requirements** -------------- Academic Qualification: Completed Bachelor’s Degree. Experience/Knowledge in the role: Routine experience in Validation activities. Foreign Languages: English (desirable). Training: As per Training Matrix. Skills: Numerical proficiency and oral/written communication; Microsoft Office Suite; Negotiation, Interpersonal Relationships, and Teamwork; Advanced Excel (desirable).**Responsibilities** --------------------- 1\. Develop validation documents, such as: User Requirement Specifications; facilitation and conduct of risk analysis meetings; validation plans, protocols, periodic reviews, tests, and reports; 2\. Execute Thermal Qualification / Process / Equipment and System tests; 3\. Document Validation Deviations, assess impacts on the validation process, and propose corrective actions; 4\. Develop Standard Operating Procedures (SOPs) / Work Instructions (WIs); 5\. Deliver and support training; 6\. Review and approve equipment calibration and validation; 7\. Review and approve process validation; 8\. Participate in project “start-up”; 9\. Develop and analyze performance indicators (KPIs), where applicable; 10\. Review and approve process validation; 11\. Comply with HSE, Quality, and Code of Conduct standards.