Report

Research Associate - AMV

Salary

₹6 - 8 LPA

Min Experience

2 years

Location

Khairatabad, Telangana, India

JobType

part-time

About the job

Info This job is sourced from a job board

About the role

Responsible for performing the qualification and calibration of analytical instruments like HPLC, UV-Vis spectrophotometer, IR and other standalone instruments (like water content, pH meter, Balances etc.,).
Responsible for execution of Analytical Method Transfer / Analytical Method Validation / Analytical Method verification / Analytical method feasibility activities for drug substance / drug product / excipients.
Responsible for qualification/ maintenance/ handling of working standards/ reference standards and impurities.
Responsible for performing RLD analysis and COA generation.
Responsible for preparation of risk assessment report of Nitrosamine / Elemental impurities / Residual Solvents.
Responsible for preparation/ review / approval of protocols / reports / standard operating procedures.
Responsible for performing investigation / reporting of the raised notification during AMV activities.
Responsible for review of the change controls.
Responsible for following cGLP/cGMP compliance in the AMV Laboratory and maintenance of Document cell.
Responsible for following good documentation practice and general cleanliness in the AMV laboratory.
Responsible for any other work assigned by head of the department / designee as on when required

Bachelor / Master Degree -Pharmacy / chemistry

HPLC

UV-Vis spectrophotometer

water content

pH meter

Balances

Analytical Method Transfer

Analytical Method Validation

Analytical Method verification

Analytical method feasibility

drug substance

drug product

excipients

qualification

maintenance

working standards

reference standards

impurities

RLD analysis

COA generation

risk assessment

Nitrosamine

Elemental impurities

Residual Solvents

protocols

reports

standard operating procedures

investigation

change controls

cGLP/cGMP

Document cell

good documentation practice

general cleanliness