Data System Administrator - Monza, Italia - Thermo Fisher Scientific

Thermo Fisher Scientific

Azienda verificata

Monza, Italia

1 giorno fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.

Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Be responsible for the administration of Computerized Systems located into the Manufacturing area. Complete administration activities according to the 'segregation of duty' policy applied into the site, working together with the System/Process Owner of the areas.

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ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES

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Manage user permission/profile for the systems assigned according to the specific department equipment ;

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Execute back up of relevant data in case of manual processes;

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Complete the periodic accounts review according to the regulatory requirement to ensure a proper system control;

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Responsible for dependable access and availability to local systems. System Administrator is therefore required to troubleshoot and fix issues that compromise system performance or work with IT service to solve particular issues.

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Collaborate on projects to meet vendor, business, and regulatory requirements.

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Lead a dedicated improvement projects as DI&Proactive Quality Department

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Collaborate to maintain the system inventory and execute the data integrity risk assessment on the legacy and new equipment to follow the plan and ensure the completion on time and the correct systems management

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Support departments during system URS and SOP issuing; follow the equipment/computer system validation activities;

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Participate to regulatory and customer audits to answer questions and demonstrate to auditors the vital controls and required competencies to maintain site license to operate;

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Write and maintain specific department procedures to ensure the correct SOD and system administration management;

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Communicate actions, compliance gaps, and commitments to respective areas involving the DI&Proactive Quality Department

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Assist in sourcing, assessing, and recommending instrumentation/equipment for purchase to ensure the continuous improvement of the equipment according to the Data Integrity Policy;

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If needed, meet with vendors to discuss software capabilities in regards to 21CFR Part 11 compliance

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Education

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Technical high school Diploma or Bachelor Degree in Information Technology, Science, Engineering, or related fields

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Technical skills

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Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP)

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Experience in 21CFR Part 11 instrumentation compliance as well as writing and reviewing SOPs

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Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)

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Professional background

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3 or more years' experience in a regulated pharmaceutical industry, or 2 years with related technical knowledge including data integrity for quality control, manufacturing or maintenance data

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Knowledge of the majors pharmaceutical electronic/computer systems

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Languages

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English (intermediate level)

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Personality traits

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Good at writing, communicating, strong interpersonal skills

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Ability to work in team

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Problem Solving

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Thermo Fisher Scientific is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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