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.
* Valuable 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 (Bavla)
🏢 Amneal India
📍 Bavla