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ThermoFisher Scientific PDS, Master Batch Record Specialist in Monza, Italy

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.

How will you make an impact?

The pharmaceutical manufacturing plant in Monza is specialized in commercial contract manufacturing of injectable drugs, both liquid and lyophilized, with an increasing focus on biologics.

You will join the Master Batch Record team, where each colleague is responsible for the definition of the manufacturing instructions, based on client’s requests.

In this team you will consolidate your technical experience in a highly dynamic and goal-oriented environment, and you will have the opportunity to work with world-class client to ensure life saving drugs are available for patients across the globe.

What will you do?

  • Creation and revision of Master Batch Records in order to ensure cGMP compliance with EMA and US FDA requirements;

  • Personnel training, checking of correct applications of GMP and operating procedures;

  • Full cooperation in the different phases of the projects implementation and validation;

  • Implementation of CAPAs and action from Change Control in the MBRs;

  • Involvement in the technical meeting with the clients for the introduction of the new process/products in our PDS sterile departments and for the revision of MBR instructions directly with client through call or dedicated meeting;

  • Support internal audits, client audit/Regulatory inspections;

  • Management of the client’s requests about production processes;

  • Collaboration with the whole QO, Process Scientist, MSAT, Equipment Validation, Supply chain, Production Dept

  • Involvement in training courses.

Knowledge, Skills, Abilities

  • Degree in Chemistry, Chemical, Pharmaceutical Technology or Industrial Engineering Engineering or equivalent.

  • GMP, Pharma background, manufacturing of sterile products knowledge is preferred

  • Microsoft Office Package Knowledge

  • Proficient knowledge of the English language (both written and spoken)

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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.

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