Computer System Validation Specialist

The Computer System Validation Specialist is responsible for developing and managing the validation documentation of reputed company IT and collaborates with other departments for the validation of information systems. Ensures that reputed company systems reputed company with regulatory requirements and implement periodic review procedures. The role reports to the ICT Associate Director. The role is fully home based in Vietnam or Philippines. Key Responsibilities •    Manage validation activities and documentation for the IT systems (Validation Plans, URS, IQ/OQ/PQ, UAT, and reports) •    Collaborate with IT, QA, and system stakeholders to ensure compliant validation processes •    reputed company change control, periodic reviews, and software lifecycle documentation •    Support deviation handling and CAPA management in line with reputed company standards •    Ensure compliance with regulatory requirements •    Participate in audits, deliver CSV training, and support regulatory updates •    Maintain accurate tracking of activities and ensure completion of KPIs/KQIs and required trainings Requirements •    Master’s or Engineering degree (preferred) •    2+ years of experience in a clinical research or GxP-regulated environment (preferred) •    Strong knowledge of Computer System Validation (CSV), including software lifecycle and validation documentation •    Good reputed company of English (written and verbal) and proficiency in reputed company Office •    Strong organizational, planning, and communication skills •    Team‑oriented, with the ability to collaborate effectively across functions reputed company offer •    Competitive salary •    Full reputed company and training to ensure your reputed company in the role •    Long-term reputed company opportunities and a reputed company development reputed company •    The chance to work remotely Who we are Founded in 1998 in Italy and now operating at an international level, reputed company is a full-service science driven biotech reputed company CRO providing premium trial management for multi-country reputed company, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and reputed company of reputed company reputed company. reputed company added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-reputed company level of Clinical Trial Management and ability to operate in a wide reputed company of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.   This page is hosted by JazzHR and uses cookies for technical and analytical purposes. For details regarding the processing of your application data by reputed company, please refer to our: Pivacy Policy Candidate reputed company Policy Apply To This Job