Job Description

　　At Thermo Fisher Scientific team, you’ll discover impactful job, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our products are safe. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our dedication to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting career with us.

　　Ferentino, Italy | Quality

　　Discover Impactful Work:

　　The resource will be part of a very stimulate environment and will ensure that the production processes for the manufacturing of sterile injectable drugs are conducted with robustness and in compliance with the appropriate standards of Sterility Assurance, the current GMP regulations, the internal procedures and Corporate Standards.

　　The role will:

　　Lead the definition and implementation of appropriate contamination control strategies (CCS) and he will assure their lifecycle management.

　　Define the strategy for Aseptic Process Simulation validation/revalidation activities, approving the APS program and defining the site EM monitoring program and its effectiveness.

　　Ensure training and oversight of activities related to asepsis/terminal sterilization processes and promote the application of good manufacturing practices in terms of aseptic behaviour.

　　Lead and provide support in the evaluation of investigations that impact the aseptic techniques and actively participating in the identification of corrective/preventive actions.

　　Receive constant training on GMP in the field of Sterility Assurance and transfer this training to the site SMEs.

　　Act as SME during regulatory and customer audits and new project introduction.

　　Represent the Site in the Corporate Sterile Working Group meetings by harmonizing the practices/procedures/processes between the various sites of the network.

　　Promote the continuous improvement in aseptic technique culture/behavior and he will implements PPI projects within SA team.

　　Coordinate and support team members with training, feedback and mentor and draws up, together with the HR business partner, appropriate plans for the development of resources, promoting the job rotation of talents.

　　Keys to Success:

　　Education

　　Minimum Bachelor’s degree required. Chemical, Scientific/Technical field such us Biology/Biotechnology, Chemistry, and Pharmacy.Experience

　　Proven experience in similar positions within a regulated environment such as pharmaceutical or biotech companies (Sterility assurance Senior manager, Microlab Manager, MS&T Manager, MSAT Manager, Process Engineering Manager)Knowledge, Skills, Abilities

　　Strong knowledge of global cGMP

　　Thorough understanding of pharmaceutical laws (EU/US), and quality management system

　　Experience in quality event management

　　Manufacturing and validation experience

　　Microbiologic Knowledge in sterile manufacturing site

　　Strong knowledge of environmental monitoring/program (viable and total particles)

　　Experienced people management

　　Strong Communication skills

　　Strong understanding of the manufacturing processes and aseptic validation

　　Personality traits:

　　Leadership

　　Marked Problem solving

　　Decision Making

　　Excellent communication & negotiation skills

　　Languages:

　　English (Excellent)Technical skills

　　GMP regulation (EU and US);

　　Specific knowledge of Sterile injectable drugs production processes

　　Sourced from Pharma FDA-approved companies;

　　Broad and sound experience with Pharmaceutical Quality Systems (e.g Trackwise) and reporting tools.

　　Based on proven experience and qualifications we are open to evaluating any potential role upgrade.

　　This is an equal opportunity employer: here in Thermo Fisher celebrates diversity and it is committed to crafting an inclusive environment for all employees!

　　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.