Computer System Validation Specialist at OPIS s.r.l.

The Computer System Validation Specialist is responsible for developing and managing the validation documentation of all IT and collaborates with other departments for the validation of information systems. Ensures that all systems comply 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 ResponsibilitiesManage 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 processesOversee change control, periodic reviews, and software lifecycle documentationSupport deviation handling and CAPA management in line with quality standardsEnsure compliance with regulatory requirementsParticipate in audits, deliver CSV training, and support regulatory updatesMaintain accurate tracking of activities and ensure completion of KPIs/KQIs and required trainingsRequirementsMaster’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 documentationGood command of English (written and verbal) and proficiency in Microsoft OfficeStrong organizational, planning, and communication skillsTeam‑oriented, with the ability to collaborate effectively across functionsWhat we offerCompetitive salaryFull onboarding and training to ensure your success in the roleLong-term growth opportunities and a clear development pathThe chance to work remotelyWho we areFounded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects. OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.

Computer System Validation Specialist

Emma

Responsibilities

Skills wanted:

Language(s) required:

Laura Ambrosoli

About OPIS s.r.l.:

mission:

www.opisresearch.com/

Admin access needed