Assistant Manager, MSTG

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Skills you'll use

What you'll do

• To Support commercial troubleshooting/remediation/Market complaints for injectable manufacturing sites at Level 2.
• To support for timely investigation/execution and to resume commercial manufacturing to meet market/sales requirements.
• To support review and approval of investigation protocol and report.
• To provide technical support at any stage of commercial manufacturing as required by site (QC, QA or Production).
• Prioritization of refer issues from site and conduction meeting for the same. Maintain the investigation tracker and update the leadership weekly.
• To collect data on intimation of failure OOS/OOT/market complaint by site.
• To review site investigation report, Product/Method development report, historical data trending by applying six sigma tools i.e statistical analysis.
• Perform exploratory literature search and review for support assigned investigation.
• Planning and execution of investigational hypothesis and generation of data as a part of investigation.
• Communication with site for root cause and suitable CAPA and participation with CFT discussion with sites.

Who can apply

• Exposure/Experience to injectable dosage form with excellent command on sterile unit operation.
• Strong understanding of equipment operation.
• Statistical data evaluation.
• Proactive approach toward Problem solving.
• Good documentation, coordination and communication skills.

About Amneal India

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