Implement quality control activities for Pharmaceuticals at Ankleshwar adhering
to regulatory / global quality Directives and HSE guidelines with optimum
utilization of resources to ensure consistent good quality of products to meet
with customers’ requirements, living Group’s Values and Code of Ethics.
REQUIREMENTS
Education / Experience
Post Graduate in Science (Organic or Analytical Chemistry )
2-5 years in a Pharmaceutical Company.
Technical skills &
Competencies / Language
* Analytical ability
* Trouble shootings
* Co ordination
* Communication
KEY ACCOUNTABILITIES
Technical expertise:
Operation and calibration of LCMS/MS instrument for the testing of Nitrosamine,
NDSRI as per current regulatory guideline.
Performing Analytical method validation/verification/transfer for Nitrosamine,
NDSRI and GTX impurities on LCMS/MS.
Troubleshooting of LCMS instruments during routine use.
Testing
Performing timely analysis of raw material, bulk product, intermediates,
finished goods and other samples for Pharmaceuticals.
Performing analysis of market complaints, Stability, process validation samples,
Cleaning Validation of Pharmaceuticals.
Testing on nitrosamine and related impurities.
Valuable Laboratory Practice
Performing calibration & maintenance of lab. Equipment and assisting for the
qualification of laboratory equipment.
Reviewing pharmacopeia's for specification preparation.
Preparing SOPs and Formats and Analytical Test Record.
Managing reference standards, working standards, laboratory reagents &
chemicals.
Arranging and observing Control Samples and maintaining record.
Participating in Investigation of out of specification results, retesting and
review the analysis records.
Maintaining & reviewing laboratory raw data related to testing activity.
Validation