Supervisor, Process - Monza, Italia - Thermo Fisher Scientific

Thermo Fisher Scientific

Azienda verificata

Monza, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

When you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery.

With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Ensure production and cleaning validation through planning, supervision, and control of validation and change management activities in compliance with current regulations (laws, GMP, FDA, etc.)of the information in the dossier and the company's quality standards.

Ensure the correct validation of processes and cleaning through the coordination and supervision of specialists in compliance with company protocols and procedures.

Ensure support to specialists to ensure the drafting of Validation Protocols through research and acquisition of data and the necessary information to define the contents of the data in other business functions, as well as involving the company functions in determining the activities they will have to carry out, in compliance with company procedures.

Ensure the availability of personnel trained in overlooking activities to attend during the APS processes, collaborating with the Sterility Assurance function in defining a shared plan and aligning with the current procedures.

Participate in audits by external bodies by providing necessary information and documentation.

Support specialists for the optimal coordination of the change control activity (change control) in compliance with company requirements and procedures.

Support the preparation and updating of Process and Cleaning Validation Master Plans in compliance with current regulations (laws, GMP, FDA, etc.), SOPs, the indications contained in the dossier, and company quality standards.

Support specialists and contribute to the analysis and evaluation of the technical documentation related to the manufacturing processes or cleaning procedures to be validated to acquire information necessary for the definition of protocols and the execution of validation activities in compliance with business procedures.

Ensure support to specialists to ensure the drafting of Validation Protocols by researching and acquiring data from other business functions and the information necessary to define their content and by involving the business functions in determining the activities to be carried out, following company procedures.

Qualifications:
Engineering Master's Degree (Chemical Engineering Preferred), Chemical or Pharmaceutical Master degree with 5+ years of experience

Prior experience in developing and/or managing personnel

Prior experience in executing process development and implementation for commercial GMP manufacturing processes including process qualification (IOQ, PPQ, RQ) and managing validation teams

Strong communication (written and verbal), collaboration, and team building skills; ability to connect with all levels of the organization

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.