Master Batch Record Compliance Specialist Monza

Master Batch Record Compliance Specialist
Monza
Lombardia, Monza

Work Schedule Standard (Mon-Fri)

Environmental Conditions Office

Job Description 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 a growing emphasis 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.

You will use your technical skills in a fast-paced environment and work with top clients to provide medicine to patients worldwide.

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 accurate 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; Attend technical meetings with clients to introduce new process/products in our PDS sterile departments and revise MBR instructions through calls or dedicated meetings.

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.

Open and coordinating quality records (change control, CAPA, RMM).

Knowledge, Skills, Abilities Degree in Chemistry, Chemical, Pharmaceutical Technology or Industrial Engineering or equivalent experience.

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

Knowledge of Quality aspect related to the Pharmaceutical manufacturing.

Outlook Package Knowledge.

Good knowledge of the English language (both written and spoken).

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