Monza site is a world class contract manufacturing facility, specialized in aseptic injectables drugs. Joining more than 900 colleagues on site, the selected candidate will experience a smart, driven, and fast growing environment. With revenues of more than $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
- Manage user permission/profile and other parameters not managed by IT for CFR 21 part 11 systems, and critical password, receipe and other parameters for not CFR 21 part 11 instrument like balances, phmeters
- According to software SOPs, manage software configuration, reset password, perform data back-up for CFR 21 part 11 systems, guard password/keys for not CFR 21 part 11 electronic systems
- Perform Audit Trail review if needed
- Manage other tasks for the functional department, not related to the administration of the instruments; support departments during SOP drafting; plan and following the equipment validation activities or other not GMP activities.
- Participate to regulatory and customer audits to answer questions and demonstrate to auditors the necessary controls and required competencies to maintain Patheon license to operate
- Write procedures and follows equipment validation processes
- Communicate actions, compliance gaps, and commitments to respective areas, including the QAC Manager and the Quality Director
- If needed, execute risk assessments to determine high risk equipment and audit trails and take appropriate action to bring into compliance. Assist in sourcing, assessing, and recommending instrumentation/equipment for purchase to ensure the continuous improvement of the equipment according to the Data Integrity Policy
- Perform training on electronics/computer systems
- 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
- Perform purchase and investment requests for new equipment or for updates/upgrade and any other activities related to administration, updating, control, maintenance and system upgrade.
- evaluation of departmental issues related to the management / optimization of the systems
- Write system SOPs follow the equipment validation activities or other not GMP activities for the department.
- previous experience, at least 1 year, in similar position in pharmaceutical company
- knowledge of systems mentiond
- good level of Italian and English, both written and spoken
To Apply, please click the following link: https://thermofisher.contacthr.com/73549627
Apply on company website