Analytical Expert

Sarvotham Care

15 - 23 years

20 - 35 Lacs

hyderabad

Posted:4 days ago| Platform:

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Skills Required

analytical method development analytical research extractable leachable method validation hplc ich

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Description:

Designation: Analytical Expert

Department: AR&D

Qualification: M.Sc. /M. Pharma/ Ph.D.

Experience: 15 to 20 Years

Key Skills:

Proven expertise in technical areas such as design and driving of Biocompatibility studies for pharmaceutical and medical devices, designing of extractable & leachable studies (USP 1663, 1664, PQRI, ISO 10993, EU Guidelines), chemical characterization of extractable, toxicological assessment of compounds, setting of GMP stability, impurity testing and characterization, method development & validations, material characterization using SEM.
Experience in driving the cGMP/Registration stability studies, including stability strategy, design, initiation, testing, data review and compilations.
Testing of nutraceuticals, and standardization of herbal drugs.
Sound knowledge in ICH, WHO, USFDA, EU-GMP, PQRI, NABL 17025 and other regulatory guidelines.

Should have knowledge on below Service

Driving E&L projects - Planning, execution, review and reporting of E&L.
E&L data compilation and reporting for regulatory section CTD 3.2.p.2.4
Support on identification and characterization of impurities.
Risk assessment for E&L requirement and provide cost effective study design.

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