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Executive - MSTG

Executive - MSTG

sun pharma industries

3 - 7 years

6 - 12 Lacs

vadodara

Posted:1 day ago| Platform:

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Skills Required

data analysis process optimization pharma analytical formulation risk assessment troubleshooting continuous improvement auditing lean six sigma

Work Mode

Work from Office

Job Type

Full Time

Job Description

Process Development and Optimization Support:(PRIMARY)

Partner with formulation scientists to ensure manufacturability and scale up feasibility.
Translate lab-scale batch data into pilot/scale-up strategies
Identify and define critical process parameters (CPPs) and key process parameters(KPPs)
Partner with FDD for process risk assessment (e.g, FMEA)
Partner with Process engineering MSTG/FDD and Conduct Scale Up studies and develop scale up model.

Technology transfer documentation:(PRIMARY)

Prepare tech transfer packages.(Process Optimization report)
Conduct Gap assessment between RD and target manufacturing sites and prepare Gap assessment executive summary for review.(Equipment, utilities, SOPs)

Process Modelling (Robustness and Optimization) (PRIMARY)

Use tools like QbD, DoE, and PAT to model and simulate processes before transfer.
Preform multivariate data analysis to assess robustness.
Exploration of PAT/Digital tools for non-oral portfolio processes

Analytical Method understanding:(CFT)

Collaborate with Analytical R D for method robustness and comparability during transfer.

Support Regulatory fillings: (CFT)

Provide data and technical justification for regulatory submissions.

Troubleshooting and Investigations: (Scale up/EBs) (PRIMARY)

Address deviations, out of spec (OOS) and process failure with root cause analysis.

Continuous Improvement:(CFT)

Reduce cycle time, enhance robustness using Lean Six sigma.

Support to QA/Regulatory:(CFT)

Provide technical input for regulatory inspections, response to deficiencies and audit queries.(Development Related)

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