QP HEAD

at  Thermo Fisher Scientific

REQUIREMENTS

• Proven experience in the pharmaceutical field
• Proven track record in the QP role, according to 219/06 legislative decree
• Proficiency in Italian and English languages
• Ability to navigate sophisticated contexts and optimally manage relationships with authorities
  At Thermo Fisher Scientific, we value diversity and believe that an inclusive workforce drives innovation and success. We are an equal opportunity employer and welcome applications from all qualified individuals, regardless of race, gender, age, disability, sexual orientation, or religion.

ABOUT THE ROLE

As the QP Head, you will play a pivotal role in ensuring compliance with all applicable laws and regulations, including D. Lgs 219/06 and later supplements. Equivalent experience will also be considered for educational requirements. Additionally, you will act as a liaison between the plant and the Italian and European Public Health Authorities, leading a team of highly skilled QPs and collaborating closely with Italian and other foreign authorities such as AIFA, EMA, and FDA.

RESPONSIBILITIES

• Act as a liaison between the plant and the National Public Health Authorities, National Public Safety Authority, and other relevant bodies in relation to drugs and controlled drugs
• Ensure that each batch of drug is produced and controlled in strict compliance with current laws and the conditions defined in the product marketing authorization
• Release finished products for the market (Batch Release) and authorize the release of unpacked products for delivery to clients
• Ensure all required documentation, as per law and Good Manufacturing Practices (GMP), is properly compiled and filed for the appropriate period of time
• Collaborate actively during inspections by Health Authorities and ensure timely compliance with any requested actions
• Certify that pharmacologically active substances used within the plant have been produced in compliance with GMP