Assistant Manager, MSTG at Hcfa (CX_5001) — Gujarat, India

About The Role

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.
Close co-ordination with QC, manufacturing, QA, RA, R&D to meet TAT.
To provide suggestions to manufacturing site for improvement in process to improve product robustness.
Record and follow up on meeting actions, metrics and improvement initiatives.

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.