(PRT) Junior CSV Manager
DSV
- Lisboa
- Permanente
- Horário completo
Time Type:PLEASE REMEMBER TO CLICK "APPLY" BUTTON AFTER SAVING YOUR PROFILE TO COMPLETE YOUR APPLICATION PROCESSJoin Our Global Team: Seeking a Junior CSV Manager to Uphold Excellence in Healthcare LogisticsEmbark on a career where precision meets innovation - become the cornerstone of our healthcare logistics, ensuring impeccable computer system validation in a role that transcends borders and sets new standards in global compliance.The Junior CSV Manager plays an integral role within a global team, working diligently to ensure the proper validation of computer systems within our logistics operations. This critical task involves ensuring compliance with relevant internal policies and healthcare regulations, international standards, and GXP (Good Practice) guidelines. This position demands close collaboration with multiple departments across diverse geographical locations to guarantee the integrity, reliability, and compliance of systems and data throughout their entire lifecycle in our global environment.In addition, this role is future-oriented, with a focus on implementing innovative solutions and staying ahead of emerging technologies and regulatory changes to ensure the continued effectiveness of our computer systems validation processes on a global scale.As a Junior CSV Manager, you will:
- Conduct risk assessments to determine the level of validation required for computer systems
- Review and document validation deliverables, including but not limited to validation plans, test protocols, and final reports
- Ensure computer systems are maintained in a validated state through periodic reviews and change control processes
- Ensure compliance with all relevant GxP and healthcare regulations pertaining to computer systems
- Stay updated with regulatory changes affecting CSV and implement necessary measures to ensure ongoing compliance
- Conduct or assist in audits and inspections related to CSV
- Work closely with cross-functional teams to ensure seamless implementation and validation of computer systems
- Supporting close collaboration with vendors and suppliers to ensure third-party systems align with internal validation standards
- Participate in identifying and implementing tools, technologies, and methodologies to enhance CSV processes
- Supporting to provide recommendations to senior management on optimising validation processes and adapting to changes in the regulatory landscape
- Bachelor's degree in Computer Science, Life Sciences, Engineering, or related field
- 1-2 years of experience in Computer System Validation, preferably within the logistics or healthcare industry
- Familiarity with GxP guidelines, GAMP5 guidelines and other relevant healthcare compliance standards
- Strong analytical and problem-solving skills
- To excel in this role, one must possess a high level of writing skills and exceptional attention to detail
- Ability to communicate effectively in a multicultural environment
- Knowledge of qualifying infrastructure is an advantage but not essential