Key Responsibilities

- 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.

Preference will be given to candidate who have following experience and skills:

- 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.
- Positive documentation, coordination and communication skills.

Qualifications Education : Master in Pharmacy Relevant experience in MSTG/Technology Transfer departments.

2 years of Minimum experience is required for Internal Job posting

📌 Assistant Manager, MSTG (Gujarat)
🏢 Amneal Pharmaceuticals
📍 Gujarat