Sr Spec It, Qsr Csi/Di Lazio

Sr Spec It, Qsr Csi/Di
Roma
Lazio, Lazio

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission.

No matter your role at Baxter, your work makes a positive impact on people around the world.

You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home.

For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other.

This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**About Us

Nothing changes if nothing changes, which is why Baxter is transforming our global IT function—into one that will strengthen partnerships and enable smarter, more efficient and connected business processes.

In the dynamic healthcare industry, we need to be ready to face new challenges and opportunities.

As we learn, we must be agile and innovative to reveal new ways of working.

Technology and our digital capability will help create a more efficient and innovative ecosystem to enable our employees, customers and products to drive better outcomes for patients worldwide.

We are at the critical intersection where robust IT infrastructure and networking support meets the physicians, nurses and care givers who save and sustain lives.

Together, we can build upon Baxter's rich heritage to advance the next generation of transformative healthcare innovations.

Together, we can change how IT meets healthcare.

Together, we are Baxter.

This is where technology fuels purpose-driven work.

Where your purpose accelerates our mission.

**Title: Sr Spec, IT - QSR

**Location: ITALY FULL REMOTE POSI

**Your Role

- Software development lifecycle (SDLC) and software validation knowledge is required for this role.

- Have clear understanding of AWS and Azure cloud specifications/components/deployments.

- Create Change Control in Service Now and manage the Change Control workflow till closure of the change in Service Now.

- Being proactive and able to make quick and right decisions.

- This position is accountable for leading and performing activities in support of the validation and compliance of a computerized system to ensure system meets its intended use.

This position will work with IT team(s) to ensure a computerized system is compliant with applicable regulations (21 CFR Part 11, GxP Regulations) and Baxter Quality Management System requirements.

- Support the Validation activities during the deployment of any new GxP Application.

**What you'll be doing

- Review project teams' work to ensure quality (design walk-through, code review, test results, etc. )

and alignment to the processes, standards, and regulatory requirements.

- Responsible for the conduct of Verification and Validation activities as per requirements defined in Baxter Design Control Method and regulatory requirements.

- Responsible for assuring the new Computerized System meets the requirements of the systems users & Regulatory requirements.

- Review of AWS and Azure cloud specifications/components/deployments.

- Review AWS Design Specification and coordinate with cloud engineer to make sure the Specification is per the intended use and as per Baxter approved template.

- Review Evidences, Checklists and code reviews and ensure it is aligned with Design Specification.

- Creating, managing, and /or maintaining the documents required by Baxter quality systems procedures for the development and validation of the Computerized System.

- Responsible for oversight of protocol execution.

- Shall control the Validation Package and shall ensure that all documents contained in the Validation Package are maintained per document retention policies/procedures.

- Coordinate risk management of new or changed computerized Systems.

- Communicate and control the adherence to validation standards by the team.

- Provide support to the functional team/users for the development of validation deliverables (functional specification, technical specification, system & user procedures, etc).

- Support the processes to maintain in a controlled state of validation during the entire life cycle of Computerized Systems.

**What you'll bring

- Bachelor's degree in science, engineering, or technology and meaningful work experience required.

- 7+ years of Validation/Quality System Assurance experience is required.

- Demonstrable experience/results in leading and mentoring project teams, accomplishing results through self and others.

- Thorough knowledge of GxP regulations (e. g.

21 CFR Part 11, GAMP 5, MHRA etc.

), Standards, and Industry Best Practices.

- Knowledge of data privacy regulation;

- Good communication skills;

- Basic project management skills

- Strong knowledge of software development/implementation processes.

- Excel