MS&T Specialist

1 settimana fa

Roma, Italia Jefferson Wells A tempo pieno

Short Role Description / Purpose :

Perform Technology Transfer (IN & OUT), process scale up and Validation at industrial scale;

Provide technical & scientific support during commercial phase to solve trouble issue (Life Cycle Management)
Main Responsibilities :
Lead the technology transfer projects by technical standpoint for products already registered.
Perform Process Validation / re-validation.
Address, in agreement with the line manager, the technical feasibility of new products including the scale up at industrial level, Process Validation pre and post registration.
Perform scale up studies and technical batches on industrial scale.
Support Quality team during Audits performed by partners or regulatory authorities as subject matter expert on technical aspects.
Implement and / or participate in existing product maintenance projects for recurring issues or collaborate on the introduction of new suppliers / third parties providers.
Perform studies related to changes of the critical components of the products (e.g. API, excipients, primary packaging) and manufacturing processes (e.g. batch size increase, process optimization, change of critical equipment) due to external factors (e.g. suppliers, cost reductions or business continuity).
Provide Technical and Scientific support during the preparation of the CTD / NDA / BLA Registration Technical Part.
Propose corrective and preventive measures to improve process robustness by developing, with the possible support of other functions, feasibility studies and related technical / economic analysis.
Assess and plan validation / re-validation / verification / periodic monitoring / batches consulting approving and reviewing the process validation Master Plan.
Writing Validation Protocols and Reports of Process Validation activities and monitoring.
Writing of Technology Transfer Plan and Report and other documents relevant to technology transfer activities.
Collaborate with the functions involved in resolving deviations and non-conformities.
Be aware and act in compliance with the relevant law, ethics and regulations and corporate procedures of the reference area.
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