Master Batch Record

Trovato in: Talent IT C2 - 3 settimane fa

Ferentino, Italia Thermo Fisher Scientific A tempo pieno

The pharmaceutical manufacturing plant in Ferentino (80km from Rome) 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 (for all the steps from solution preparation until packaging activities) 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 in the MBRs; Involvement in the technical meeting with the clients for the introduction of the new process/products in our sterile departments and for the revision of MBR instructions directly with client through call or dedicated meeting in situ; Management of the change control from the opening until the closing; Active participation in internal audits, client audit/Regulatory inspections; Management of the client’s requests about production processes; Collaboration with the whole QO, Technology Transfer, Engineering&Equipment Validation, Supply chain, Production Dept Management of changes in secondary packaging materials in collaboration with logistics and PCK development; 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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