Computer Software Validation IT Specialist
2 settimane fa
41037 Mirandola, Province of Modena, Italy Req #203
Thursday, November 9, 2023
About Mozarc Medical
At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world's largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.
Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients' lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical.
Position Title: Computer software validation IT specialist
A Day in the Life
As an Computer software validation IT specialist you will be a part of the Application Support Team within the global IT department. You will support the maintenance and the deployment of business applications, related to the processes managed mainly with SAP – ECC and S/4, but as well as PLM systems, etc.
This role will be based in Italy, but you will be supporting also other countries and therefore Hybrid/Remote way of working is possible.
Responsibilities may include the following:
- Define validation approaches for computerized systems owned by Group IT (e.g., ERPs,, PLM, LMS, LIMS, Quality Systems (Capa, audit), RIM, etc) in alignment with the CSV framework and other applicable regulations or procedures:
- Evaluate the criticality and complexity of systems to determine appropriate validation strategies.
- Develop and maintain CSV documentation, including validation plans, protocols, reports, and traceability matrices.
- Ensure proper documentation of validation activities, deviations, and change control processes.
- Collaborate with system owners, stakeholders, quality analyst, and validation teams to ensure effective validation processes.
- Manage, lead, and/or support CSV projects together with internal employees and external consultants as needed:
- Take responsibility for overseeing CSV projects, ensuring timely and successful completion.
- Collaborate with internal teams and external consultants to ensure project objectives are met.
- Manage, lead, and/or support the qualification of software and infrastructure components supporting regulated systems:
- Develop qualification strategies for software and infrastructure components.
- Collaborate with relevant teams to ensure effective qualification processes.
- Monitor and assess the compliance status of computerized systems.
- Provide consultancy regarding CSV compliance within the Group IT and other stakeholders as needed:
- Act as a subject matter expert on CSV compliance and regulations.
- Provide guidance and support to Group IT teams and stakeholders on CSV-related matters.
- Conduct training sessions or workshops to promote awareness and understanding of CSV compliance
- Support and participate in Group IT Quality-related audits (regulatory audits):
- Collaborate with audit teams to prepare for and participate in quality-related audits.
- Assist in gathering and organizing documentation and evidence for audit purposes.
- Address audit findings and implement corrective actions as required
Must Have:
- Master's or Bachelor's degree in IT, Quality, Engineering, or a related field of study.M
- Min. 2 years of experience in the field of Computer Systems Validation (CSV) and/or Quality Management Systems.
Nice to Have:
- SAP 4/HANA experience will be considered as an advantage as well as Windchill solutions
- Successful management of at least two projects (implementations) in a Validation or Quality-related role.
- Experience with validation of cloud-based applications and/or infrastructure.
- Good knowledge of applicable regulations and standards related to computer system validation: ISO 13485, FDA's QSR, GAMP5, ITIL.
- Very good knowledge of ERP systems and applications, in particular SAP.
- Strong project management skills to plan, execute, and deliver validation projects within defined timelines and budgets.
- Excellent written and spoken English,
- Effective communication, intercultural, and networking skills with the ability to work independently in a well-structured and systematic manner.
- Proactive and structured way of working, with a solution-oriented mindset and the ability to work collaboratively in a team.
- Flexibility and adaptability in a fast-paced environment.
- Proficiency in using quality tools, software, and technologies relevant to computer system validation and quality management.
- Strong analytical and problem-solving skills to identify and address validation gaps and deviations
- Other languages - it's a plus (German and French in particular)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Is this is the position you were waiting for? Apply here
- 41037 Mirandola, Province of Modena, Italy
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