Education / Experience
M.Sc. or Higher Qualification in Analytical/Organic/Applied/ Pharmaceutical
Chemistry.
Min. 12- 15 years’ experience in a Quality Control/Analysis laboratory in a
cGMP/ISO workplace, with exposure to QC operations in Pharmaceutical/API
manufacturing company
Technical skills &
Competencies / Language
Analytical ability
Trouble shootings
Co ordination
Communication
Leadership
Problem solving.
Team building
JOB PURPOSE
Generic
Implement quality control activities for Pharmaceuticals at Ankleshwar adhering
to regulatory / global quality guidelines 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 Ethics.
KEY ACCOUNTABILITIES
Testing and release
Planning of timely sampling and analysis and review of raw material, bulk
product, intermediates, finished goods, packing material and other samples for
Pharmaceuticals.
Performing analysis of Raw Material Samples received from recent vendors for
Pharmaceuticals.
Planning For analysis of market complaints, Stability, process validation
samples and Cleaning Validation of Pharmaceuticals.
Approval / Rejection of Raw Materials, Packaging Components and in process
material.
OOS/OOT/Deviation investigations
Review of analytical, chromatographic and computerized data for intermediates,
and APIs for Chemistry Ankleshwar.
Timely completion of calibration and calibration of laboratory instrument
Support troubleshooting of QC instruments
LIMS management and support to QC operations
Positive Laboratory Practice
Planning for calibration & maintenance of lab. Equipment and assisting for the
qualification of laboratory equipment.
Reviewing pharmacopeias for specification preparation.
Preparing SOPs and Formats and Analytical Test Record.
Managing reference standards, working standards, laboratory rea