QA Deviations

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, a strong GMP background as well as effective interpersonal skills will be key. You will be involved ing 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. 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:

• Review Master Batch Records, perform Batch Record Review and generate supporting documentation for batch release

• Review and manage deviations, investigations and complaints, in collaborations with all relevant functions

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

• Contribute 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.

• Provide quality support to customers by responding to inquiries.

• Conduct training for personnel involved in Quality activities for PDS.

How will you get there?

Required Skills and Experience:

• Degree in Chemistry/ CTF/ Biological Sciences or similar fields

• Multi-year experience in Quality Assurance Operations teams, with a focus on deviation management and support to GMP manufacturingExcellent knowledge of GMP and national/international regulations

• Ability to write, handle and review GMP documentation (Quality Agreement, CAPA…) and understanding of main quality indicators such as RFT (Right First Time) and OTD (On-Time Delivery).

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

• Italian and English

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.