IT Qualification Expert

hace 2 meses

Barcelona, España Ambit BST A tiempo completo

We are looking for an "**IT Qualification Expert & Project Manager**" with experience in pharma, to work directely to one of our clients.

**MISSION & TASKS**:

- Ensure the compliance of the infrastructure components with the required regulations and guidelines by the different national and international authorities, being involved in multidisciplinary projects, giving support to infrastructure qualification activities.
- Establish and implement the infrastructure qualification strategy for infraestrucure projectes and upgrades in accordance to regulatory requirements, industry best practices, and organizational needs. in collaboration with QA Department. This includes defining the scope, objectives, and timelines for qualification activities.
- Risk Management: Identify potential risks associated with the IT infrastructure and propose mitigation strategies. Conduct risk assessments and collaborate with relevant stakeholders to address and mitigate any identified risks.
- Participate as assessor in change control processes to assess the impact of infrastructure changes on qualification status.
- Ensure the maintenance of the qualification status perfoming periodic review and coordinating the preiodic testing as the BCP/DRP testing.
- Create and maintain the infrastructure qualification documentation: Qualification plan, protocols, test scripts, reports, instalation plans, Disaster Recovery, Backup Testing, Archive testing, etc. Ensure that all qualification activities are properly documented and adhere to established procedures and guidelines.
- Support internal and external audits. Prepare for and participate in internal and external audits or inspections related to IT infrastructure qualification.
- Infrastructure Project manager in projects with a strong GxP component.
- Participation in Budget elaboration.

**REQUIREMENTS**:

- Computer Bachelor degree
- At least 5 years of experience in a similar position.
- Infrastructure qualification.
- GxP guidelines
- 21 CFR part 11
- GAMP

❀ **_APTITUDES & ABILITIES:_**
- **Technical knowledge**: A strong understanding of IT infrastructure components, including networking, servers,

storage, backup, virtualization, cloud computing, and security protocols
- **Quality Assurance**:A focus on maintaining high-quality standards throughout the infrastructure qualification

process, ensuring that systems meet the required specifications.
- **Communication skills**:Good communication skills and be able to explain technical concepts to non-technical

colleagues and end-users.
- **Documentation Skills**: Proficiency in creating detailed documentation, including infrastructure qualification plans,

test protocols, and validation reports.
- **Time management skills**: Manage time effectively and prioritize tasks to ensure that projects are completed on

time and within budget.
- ** Attention to detail**:Have a keen eye for detail and be able to identify potential issues before they become major

problems.
- **Adaptability**: The ability to adapt to changing technology and business needs.
- **Collaboration**: Be able to work effectively with other members of the IT team, as well as end-users and

stakeholders from other departments.
- **Analytical thinking**: Be able to analyze data and information to make informed decisions and solve complex

problems.
- **Continuous Learning**:The willingness to stay updated with the latest technologies, industry trends, and best

practices in IT infrastructure qualification to ensure a high level of expertise.
- **Ownership**: High degree of ownership, entrepreneurship, self-initiative and follow through

**SCHEDULE**:

- 07/09h -16/18h from Monday to Friday - 40h per week (flexible)
- 50% of office work | 50% days by remote.

**CONDITIONS**:

- Direct contratc with the client.
- Own dinning room (4€)
- Flexible Retribution Program (medical insurance and pension plan)
- Learning Ad-Hoc & Development
- And much more...

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