Validation Manager (BI omgeving)

Voor een directe klant van Active Professionals, zijn we op zoek naar een Validation Consultant;

Within Data and Application Architecture Business Intelligence (DAA BI) team, validation manager shall provide Computer System Validation (CSV) support to existing team for new or ongoing IT projects. The core purpose of validation management is to ensure documented evidence is established in a risk-based, pragmatic, value-adding manner, which provides a high degree of assurance that a specific computer-related system will consistently operate in accordance with pre-determined specifications.

Essential Job Responsibilities

• Act as CSV representative for global DAA BI solutions and cooperates with BI team members and other validation specialists within the client.

• Develop validation life cycle documents such as Validation Plan, Validation Summary Report and other relevant documents.

• Ensure systems & processes comply with defined System Development Lifecycle and Computerized System Validation requirements and industry best practices.

• Participate as project member in computer system projects (implementation, upgrade or retirement projects), ensuring that CSV expertise is represented in all computerized systems projects.

• Provide quality validation support and training to those departments implementing new applications or changing existing validated applications.

Organizational context.

• Reports to the Director of DAA BI. Works closely with the BI Lead CSV and project manager of the assigned project(s).

• Interacts and cooperates with the other DAA BI team members including Support Team (onsite and offshore).

• Interacts with and influences stakeholders (Process Owners, System Owner/R&D and Project Managers, Application Managers, IT staff, Software Vendors, CSV contractors) to perform the necessary validation activities.

• Communicates with and influences Platform Owners/Process Owners/System Owners to create awareness in working with validated systems.

• Communicates with other Validation & QA related roles within the organization worldwide.

• Interacts with representatives of Quality Assurance.

Required Qualifications

• University degree in an IT related topic or comparable education and/or work experience.

• Experience in regulated industry; pharmaceutical experience is preferred.

• Knowledge and experience in the System Development Life Cycle (SDLC) and Computer System Validation (CSV) including basic documents mandatory for each phase.

• Experience using SharePoint is a plus.

• Knowledge and experience with at least one Document Management System (DMS): Documentum is a plus.

• Knowledge of regulatory requirements concerning (automated systems used in) Clinical Trials, such as GCP, GAMP and 21 CFR part 11 is a plus.

• Knowledge of Business Intelligence enterprise solutions (DWH) is preferred.

• Good knowledge of English (verbally and written).

• Advanced verbal and written communications skills, including the ability to be both directive and collaborative.

• Ability to acquire new skills as part of the job.

• Be stress-resistant

• Flexibility to work alternate shifts on an as needed basis

• Ability to work autonomously.

• Good presentation skill

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Startdatum

September

Aantal uur

minimaal 24

Duur

4 - 6 maanden + verlenging

Tarief

Open (fair)

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