Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements.
Review of laboratory data, instrument logbook and reports wherever applicable.
Initiation of departmental CCR's and tracking the progress to execute the proposed changes through QMS system.
Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites.
Procuring respective samples and Impurities accordingly.
Planning and executing the assigned TAP projects to various sites.
Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation.

A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
Knowledge of the instrumentation such as HPLC, GC, spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques.
Knowledge in HPLC method development and method validation.
Knowledge on preparation and review of various documents like SOP's, Formats, Protocols, Reports, analytical data, investigation and deviation reports.
Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities.
Should possess troubleshooting knowledge on Instruments and analysis.
Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems.
Working knowledge of LIMS is an asset.
Good written and verbal English communication skills.
BSc with 5 years or MSc with 3-4 years’ experience in a pharmaceutical lab in an R&D environment.
Chromatographic method development and validation.

Accommodation for applicants with disabilities as part of its recruitment process.

Research Scientist – Analytical Development

Key skills