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Sentiss Pharma
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Research Scientist - Documentation Cell

Research Scientist - Documentation Cell

3 - 7 years

|

5 - 8 Lacs

Posted:21 hours ago| Platform:

Apply

Skills Required

Documentation GTP Specifications SOP DMF STP

Work Mode

Work from Office

Job Type

Full Time

Job Description

To help in coordination of spcification committee meetings.
To prepare and review GTPs, Specification and STPs of API / FG for New products.
To prepare and review spcifications / STPs / GTPs of the RM/excipients/API/FG for Commercial and CML Products.
To coordinate with all concerned departments at R&D and Plant for timely approvals of documents.
To review vendors COAs for RM/excipients/API.
To Respond the regulatory queries related to analytical documents.
To archive the backup raw data respective to the documents prepared.
To review NDs and ensure there compliance where required.
To review the latest Pharmacopeias and their implementation in existing documents preferably API, excipients and FG.
To provide information to the all the stakeholders regarding updates in pharmacopeia.
To prpare TTDs for ANDA projects for API/RM/FG.
Review of DMF,Vendor change notification and vendors documents.
Prparation of Dpartmental Budget
Other Mis. Activities assigned by management

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Pharmaceutical Manufacturing

Gurgaon Haryana

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