Validation Specialist

Role Overview: You will be responsible for documentation and execution of qualification activities. This includes preparation, review, and execution of various documents such as URS, DQ, FDS, UTM, IQ, OQ, PQ, RQ, and risk assessments. Your role will involve managing FAT and SAT for new projects, reviewing raw data and test reports, and preparing final summary reports. You will also be responsible for protocols and reports for validation processes, initiating CRNs, implementing CAPAs, and conducting incident investigations. Additionally, you will prepare and review VMP, provide training, update SOPs, and assist in inspections. Key Responsibilities: - Preparation, review, and execution of qualification documents - Review of miscellaneous qualification documents and risk assessments - Management of FAT and SAT for new projects - Review and compilation of raw data, certificates, and test reports - Preparation and review of protocols and reports for validation - Initiation and closure of CRNs, and review and approval of CRNs - Implementation of CAPAs and handling incident investigations - Preparation and review of VMP - Conducting training for employees and external vendors - Preparation, review, and updating of qualification SOPs - Conducting investigations as a site investigation team member - Preparation, updating, and execution of qualification schedules - Providing assistance and support during inspections Qualifications Required: - Bachelor's degree in a relevant field - Previous experience in qualification activities - Strong understanding of regulatory requirements - Excellent communication and organizational skills - Ability to work effectively in a team and independently - Detail-oriented and analytical mindset - Experience in handling CAPAs and incident investigations - Knowledge of validation processes and documentation (Note: No additional details of the company are provided in the job description),