Qualified Person Mrna Unit (Atmp) Monza

Qualified Person Mrna Unit (Atmp)
Monza
Lombardia, Monza

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.

Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.

Our distributed team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

mRNA business unit at Monza site is looking for a Qualified Person,

**What will you do?

- Acting as liaison between the mRNA Business Unit and the National Public Health Authorities (AIFA, UCS), National Public Safety Authority (Police, National Exercise and tax crimes authority, ASL) in regard of drugs and controlled drugs.

- Assure that each batch is produced and controlled in compliance with current laws and with conditions defined in the product marketing authorization.

- Certify and attest on specific documentation that each batch is produced in compliance with the provisions indicated in the product marketing authorization.

- Release the finished products for the market (Batch Release).

- Guarantee that all documentation required by law and by GMP is properly compiled and filed for the right period of time.

- Communicate immediately to AIFA and to the Company any substantial irregularity in the products already launched in the market.

- Collaborate actively in occasion of each inspection by Health Autorithies and guarantee that any action requested by the Authorities during the inspection is made.

- Certify that the pharmacologically active substances used within the plant have been produced in compliance with GMP.

- Based on the Monza site expertise the QP will support the Quality System for mRNA business, Data Integrity program and compliance.

**How will you get here?

**Education**:

- Degree in a Scientific Area

**Experience**:

- Proven experience in Pharma Operations.

- Experience in Quality Units of pharmaceutical company.

- Experience in people management and development

**Knowledge, Skills, Abilities**:

- Knowledge of Sterility Assurance.

- QP nomination by AIFA and proven experience in the ATMP sector for at least 2 years

- Italian+English

- Leadership, including change management

- Collaboration

- Listening, negotiation and communication skills

- Critical thinking

- Pragmatic and oriented to prioritization and results achievement

Thermo Fisher Scientific is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Join us !