Csv Specialist

**Position**:
The Computer System Validation Specialist is responsible for developing and managing the validation documentation of all IT systems included in the OPIS inventory marked as GxP Critical and collaborates with other departments for the validation of information systems. Ensures that all systems comply with regulatory requirements and implements periodic review procedures.

**Duties & Specific Tasks**:
Develop and manage the validation documentation of all the IT systems included into the OPIS inventory marked as GxP Critical; in particular to manage and coordinate the drafting of Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ / OQ / PQ), User

Acceptance Testing, Traceability Matrix and Validation Reports in collaboration with System Owners, System Administrators and the System Analyst and Programmers;
- Support and monitor the correct management of Change Control of information systems;
- Support the development and management of software life-cycle SOPs and validation documentation;
- Implement the Periodic Review procedures;
- Support resolution of system deviations/errors and management of CAPAs related to information systems in accordance with quality requirements and GCPs;
- Ensure that the systems comply with regulatory requirements including 21 CFR Part 11 regulations;
- Cooperate with other Units for the validation of information systems;
- Participate in the Audits relative to the Computer System Validation;
- Conduct the Computer System Validation Training;
Cooperate with the CSV and ISO System Manager;
- Monitor the updating of the specific CSV regulations applicable to OPIS Group and support their implementation, promptly updating the Head of Information and Communication Technology.

**Qualifications/Requirements**:

- Master’s Degree, Engineering Degree preferred;
- At least two years of work experience in clinical research field are preferred;
- Knowledge of 21CFR Part 11 and GAMP V;
- Knowledge of Computer System Validation process with focus on the software life cycle and the validation documentation management;
- English Fluent;
- Good knowledge of Microsoft Office;
- Planning and organizational skills;
- Communication skills;
- Team-working oriented.
- OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects._
- OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training._

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