Job Description:

Candidate required for the role of Analytical scientist in Analytical development lab – RM/PM team to support API evaluation.

Position / Job Title - Executive/Sr Executive
Department - Analytical Department – RM/PM team
Reporting To- Manager
Location- Thane
Years of Experience - 5-10 yrs
Dosage Form - NA

Job Responsibilities / Deliverables
•Perform analysis of API samples for Assay, RS, Residual solvents, particle size distribution, Identification, water content using HPLC, GC, Malvern Mastersizer,etc.
•Perform method development, method validation/verification for API.
•Review DMF and evaluate methods reported by API manufacturer.
•Perform calibration of equipment/instruments as per schedule.
•Coordinate with QC and R&D teams and work independently to meet timelines
•Ensure compliance with ICH, GMP, GLP, and data integrity requirements
•Follow the system / operational SOP’s.
•Ensure data integrity and accuracy of supporting data
•Perform method transfer activity at different sites.
•Handle change process and QMS activities as required.

Qualifications & pre-requisites
•M.Sc. in Analytical Chemistry or Organic Chemistry
•Hands-on experience with HPLC, GC, UV, IR, TOC, IC, KF, Particle Size Analyzer
•Sound knowledge of USP, Ph. Eur., IP, BP analytical methods for APIs and excipients

Additional notes
•Role is expected to work in all shifts and based on the business requirement, need to travel to plants for analysis and document related activities.