Team Leader-Analytical R&D (MS&T)

JOB Description:

Years of experience: Minimum 5 Years.

Qualification: M.Pharm / M.Sc

Key Area: Analytical method development, Method validation, stability analysis, routine analysis, wet lab activity, GLP and GDP.

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Analytical Test Procedure Development:

He must be aware of regulatory requirements of various countries, conduct and record required literature study, identify and shortlist alternative testing methods, identify and recommend most suitable method IN ORDER TO ensure appropriateness of the testing method. Ensure the generated data for the compliance.

Method Validation:

He must be aware of method validation of testing procedures, record results against various parameters, compare and evaluate against expected results IN ORDER TO ensure ruggedness of the test procedure developed.

Stability Program Management:

He must be aware of regulatory guidelines, identify appropriate stability testing requirements, receive and conduct appropriate stability tests, record results IN ORDER TO ensure product robustness. Ensure the stability testing to be performed as per the STP and evaluate the data. Investigate the odd observation and close the documents with proper justification.

Laboratory Testing:

He must be aware of Receive and analyse product samples during various stages of product development and line testing for external locations, compare and analyse results against expectations, record and submit results IN ORDER TO provide timely information. Ensure the procurement of the reagent, chemicals, and columns have been done during the time of the initiation of the project.

Documentation:

He must be aware of Prepare documentation of specifications and test procedures, review pharmacopeias and update documents accordingly, seek approval and submit to user departments IN ORDER TO ensure proper documentation and technology transfer to production location.

Safety & Good Laboratory Practice:

He must be aware of laboratory safety in daily activities in the laboratory. Ensure the compliance of the instruments, columns, Working and reference standards as well as the calibration records of the instruments.

Instruments/Equipment’s to be Handled:

1. High Performance Liquid chromatography

2. Gas chromatography

3. Analytical Weighing Balance

4. pH Meter

5. Auto titrator

6. Dissolution Apparatus all the types

7. IR Spectroscopy

8. Viscometer

9. Ion Chromatography

10. Malvern master sizer

11. UV Spectroscopy

12. Osmometer,

13. Particulate matter