Manager - MSAT (Upstream)

Lupin

10 - 15 years

15 - 20 Lacs

pune

Posted:2 weeks ago| Platform:

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Skills Required

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Job Type

Full Time

Job Description

Role & responsibilities

Responsible for upstream manufacturing process support, data acquisition, and trending.
To manage statistical analysis of manufacturing batches data using statistical software like Minitab, etc.
Lead the upstream team in troubleshooting and process related deviation investigations activities to identify the root cause followed by providing an effective CAPA.
Plan, evaluate and manage the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing).
To collaborate and communicate regularly with R&D teams in execution of experimental runs and any other scale down experiments to support manufacturing process changes/improvements.
Planning and successful implementation of process changes in upstream manufacturing processes with relevant CFT consensus.
Responsible for risk assessment, validation protocols, validation reports and facility fit assessment applicable for upstream processes.
Review of technical documents i.e. manufacturing batch records, SOPs, study protocols, study reports and cleaning validation documents etc.
Coach, mentor and train upstream team members in skill development.

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