OPIS

Role Description 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. - 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 - Oversee change control, periodic reviews, and software lifecycle documentation - Support deviation handling and CAPA management in line with quality 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 Qualifications - 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 command of English (written and verbal) and proficiency in Microsoft Office - Strong organizational, planning, and communication skills - Team‑oriented, with the ability to collaborate effectively across functions Benefits - Competitive salary - Full onboarding and training to ensure your success in the role - Long-term growth opportunities and a clear development path - The chance to work remotely Company Description Founded 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. - 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.

• Overseeing client relationships and contributing to strategic business growth • Managing critical processes such as Requests for Proposals (RFPs) • Collaboration with cross-functional teams • Leading and participating in client meetings, presentations, and bid defense meetings • Developing and presenting sales materials and strategic proposals • Managing the RFP process to ensure timely and accurate inputs • Maintaining strong relationships with potential clients • Supporting vendor selection processes and reviewing quotations • Identifying business development opportunities • Ensuring compliance with key performance indicators (KPIs) and quality standards • Completing required trainings and maintaining accurate records