PURPOSES OF THE POSITION/RESPONSIBILITIES:

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

ASSIGNMENTS , SPECIFIC/PRIMARY ACTIVITIES:

• Manage user permission/profile not managed by IT for CFR 21 part 11 systems and password, recipes and other parameters for not CFR 21 part 11 instrument like balances, pH-meters;

• Password resetting management; user identification and verification; create, update, unlock, disable, re-enable application specific accounts upon approved request;

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

• Coordinate with site Maintenance (Electrician) to reset account and to give immediate troubleshooting;

• Support departments during system SOP drafting; follow the equipment/computer system validation activities;

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

• Write specific procedures an maintain their own managed computer system list according to SOP for SOD;

• Communicate actions, compliance gaps, and commitments to respective areas involving the DI & QRM Manager;

• Join the DI risk assessment an Quality risk Assessment, when needed, helping to determine risks for equipment and System;

• Support the relevant functions in review the Audit Trail of the systems;

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

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

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