Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer! We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

You will join the Quality operation team dedicated to support our Pharmaceutical Development Service Unit, an innovative facility where we support clients in manufacturing clinical trial batches of sterile injectable products.

Working in a young, dynamic and very exciting environment, you will have the possibility to build a strong GMP background as well as effective interpersonal skills while interacting with multiple functions in the site. You will be involved in project meetings both for new and ongoing projects and will be the owner of the related GMP documentation (i.e. PSF, APR, Quality Agreements, SOP…) and quality operations activities needed to ensure batch release, as well as the relationship with external clients. You will enjoy a first hand oversight on process development and scale up of life-saving and innovative drugs, where your contribution will make the difference!

Responsibilities:

- Ownership of project meetings and accountability for all QA-related topics.

- Support in the organization of technical and managerial meetings with clients and participation in customer visits and audits by customers and/or regulatory authorities.

- Review and management of deviations, investigations and complaints, in collaborations with all relevant functions.

- Contribution to achieving "zero past due" objectives in Quality (CAPA, Complaints, Deviations) within one's scope of responsibility, as well as RFT (Right First Time) and OTD (On-Time Delivery) objectives for document submission to the client and lot release.

- Involvement in quality support to clients  by responding to inquiries.

- Generation of all supporting documentation to allow batch release.

Required Skills:

- Degree in Chemistry/ CTF/ Biological Sciences or similar fields.

- Good problem-solving abilities, excellent communication and team working skills and ability to prioritize under time constraints.

- Italian and English.