Job Description

　　Job Description

　　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 outstanding 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.

　　Discover Impactful Work:

　　You will join a new mRNA GMP facility in Monza and participate in the general compliance of the mRNA site by providing advice on licensing strategies applicable to the innovative mRNA product, collaborating with our Customers, Quality, Supply Chain, Production and QC team.

　　You will be a key support to the mRNA business growth and being the quality supplier management specialist and contact point for new projects, while you will be in contact with customer’s technical/quality counterparties, promote our service offering and facilitate supplier qualification.

　　Support the head of the Quality Service in ensuring the compliance of the company to the quality regulations in force (laws, GMP, FDA, ATMP), through the management of the qualification of suppliers and their compliance with company policies and regulation.

　　A day in the Life:

　　Supplier audits, will be proposed under the supervision of the head of Quality Service to ensure the implementation of an annual plan of external audits suppliers, aimed at verifying compliance with corporate regulations and requirements, to highlight gaps to be filled, through the definition of corrective actions.

　　Quality Agreement, Supporting the head of Quality Service to ensure the implementation of the Quality Agreement with the supplier in compliance with current regulations (laws, European and international GMP standards and company standards).

　　Supplier approval will be done with the support of the head of the Quality Service through the definition and updating of a supplier list in compliance with current regulations (laws, GMP, FDA, ATMP).

　　Supplier Complaints will be done with the support of the head of the Quality Service to ensure the management of complaints to suppliers and reports to customers, in compliance with current regulations (laws, European and international GMP standards and company standards) and within the time frame agreed with Quality Operations.

　　Internal audits, Ensuring the smooth conduct of internal audits, inspections, through the planning and execution of assigned tasks, the definition of corrective actions / preventive of the relative responsibilities and time of implementation, in order to allow the smooth performance of the activities regulated by GMP, in compliance with current regulations (laws, GMP, FDA, ATMP).

　　Follow up audit and management of corrective/preventive actions (CAPA), Support of the head of the Quality Service to ensure the definition of actions of adaptation to customer requests arising from audits, through the verification of consistency with current regulations, the definition of the responsibilities and the timing of the implementation of corrective actions, the activation of the functions concerned and the supervision of compliance with the defined times and requirements, in order to allow the acquisition of orders and to allow the smooth performance of the activities regulated by GMP, in compliance with current regulations (laws, GMP rules, CFR 21, ATMP), customer indications, business interests.

　　Quality, operate in order to ensure compliance with company quality standards, through the application of procedures, the implementation of corporate standards related to areas of competence in compliance with company quality policies and procedures.

　　Regulatory Knowledge & Expertise, Advance knowledge on Italian laws and regulatory environment by leaning into specialized industry trade association working groups, digest and disseminate information, assist in impact assessment and implementation.

　　Keys to Success:

　　REQUIREMENTS AND QUALIFICATIONS: Degree in Chemistry, Pharmacy or Biology or diploma with proven experience,

　　Technical and computer skills: Office,

　　Languages: English,

　　Personality: Attention to Detail, Planning Skills, Interpersonal Skills

　　REPORTS: All business and External functions, Suppliers, Customers during visits,

　　Adaptable to a dynamic work environment,

　　Agile interaction with interfaces, customers and other external partners,

　　Customer-centric attitude with strong corporate driver,

　　Ability to work with cross-functional teams and in a matrixed environment,

　　Ability to prioritize workload to meet timelines.

　　Adhere to OHS policies and procedures and ensure safe and healthy workplace environment.

　　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!

　　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.