Quality Operations Intern

ThermoFisher Scientific; Monza; On-site; EUR 6,700 - 10,000; Full time

Job summary

Thermo Fisher Scientific in Monza, Lombardy invites a QOPS Intern to support batch release documentation, deviations reviews, CAPA analysis, and customer complaint handling under GMP guidance.

This paid university placement (6-12 months) targets graduate students in Chemical Pharmaceutical or related fields; no prior work experience required, strong Microsoft Office skills expected.

Qualifications

• Graduate student in Chemical Pharmaceutical or related field.
• Current enrollment in Master’s program or graduated within the last year.
• Good computer literacy with Microsoft Office applications (Outlook, Word, Excel, PowerPoint).

Responsibilities

• Support release documentation review and completion of release checklists.
• Assist with review of deviations and investigation reports, CAPA analysis, and documentation archiving.
• Assist with handling customer complaints under GMP-related procedures.
• Provide QA support for commercial production and liaise with relevant departments.
• Assist in audit preparation and management with Team Leader guidance.

Education

Master’s degree in Chemical Pharmaceutical or related field

Tools

Microsoft Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.

Project Scope and Responsibilities:

Reporting to the relevant QOPS Team Leader and the QOPS Supervisor, the QOPS Intern supports the team in verifying documentation relating to production batches and in carrying out preparatory activities for product release.

Under the guidance and coordination of the Team Leader, assist with the review of deviations and the associated investigation reports, as well as the handling of customer complaints, in accordance with company procedures and applicable regulations (GMP, FDA, etc.). Will also support the team in Quality Assurance activities relating to commercial production and in liaising with the relevant company departments.

Project activities may include the following responsibilities:

Preparation for the Release of Commercial Batches:

Assists with the review of batch documentation and the completion of release checklists, verifying their completeness and compliance with SOPs and applicable regulations. Assists the Team Leader and the Qualified Person with the preparatory activities prior to batch release.

Review of Deviations and Investigation Reports:

Assists with the review of deviations and related investigation reports, verifying their completeness and compliance with company procedures. Assists with the analysis of root causes and any corrective and preventive actions (CAPA), collaborating with the relevant departments. Assists with the management and archiving of the relevant documentation.

Complaints Management:

Assists with the review of customer complaints and related investigations, helping to collect and verify the necessary documentation. Assists the team in preparing the information required for communications with the customer.

Audit Support:

Assists the Team Leader in the preparation and management of customer and regulatory authority audits. Quality: Works in accordance with procedures, company quality standards and applicable GMP regulations.

How will you get here?

Graduate student completing a Master’s degree in Chemical Pharmaceutical or related fieds.

Students must either (1) be currently enrolled at a university and about to enter their final year of study or (2) have graduated no more than one (1) year before the anticipated start date.

This position will fulfill a 6-12months university placement within the curriculum.

No previous work experience is required; previous related internships, apprenticeships, academic projects, or experience with document/data management activities are considered an advantage.

Good computer literacy, with experience using Microsoft Office applications, particularly Outlook, Word, Excel, and PowerPoint.

To qualify, applicants must be legally authorized to work in the Country indicated for the opportunity they are applying to by either confirming Citizenship or the right to work.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.