- Location
- India - Alathur
- Type
- Full-time
- Department
- Education
- Seniority
- Entry
- Source
- Workday
Description
Job Description Summary
We are seeking a highly motivated analytical R&D chemist to join our research and development team.We require 4 to 7 years’ experience and post graduate chemistry/Analytical in developing and validating analytical methods for testing of API and release according to ICH and regulatory requirements.
Having through knowledge of GMP operation and ability to work on Wet analysis and analytical instruments HPLC/GC/GCMS/IR/LCMS.
Job Description
To ensure good housekeeping and adhere to GLP/cGMP norms in ARD Lab and maintain cleanliness of instruments and equipment’s.
To support and perform analytical method Development for each project timely.
To support and perform analytical validation/Method transfer for each project timely
To support regulatory requirement as per committed timeline.
To provide analytical support related to production for sorting out issues, yield improvement and further optimizing the process as per schedule.
To Sample/analyze RM,KSM, in process, cleaning, intermediate, stability and API and report preparation
To Analysis and documentation of Reference standard samples as per MTH
To support and perform analytical method development/Validation for EI by ICPMS and,IC,GCMS LCMS timely.
To ensure completion of documents & data integrity and regulatory environment
To support for Calibration/Preventive maintenance of all analytical instruments
Review of all executed analytical documents.
Maintenance for HPLC /GC Columns.
To perform Partial validation, Holding study, DMF queries and physiochemical studies
Responsibility for QMS system like Change control, Deviation and CAPA and related to QMS.