PDS Master Batch Record Specialist

Work Schedule

Environmental Conditions

Job Description

Work Schedule Standard (Mon-Fri)

Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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

You will become a part of the Master Batch Record team, where each team member is tasked with crafting the manufacturing instructions, following the specifications provided.

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
• Outlook Package Knowledge
• Good knowledge of the English language (both written and spoken)

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