REQUIREMENTS
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 environment, 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 valuable quality of products to meet with customers’ requirements, living Group’s Values and Code Ethics.
KEY ACCOUNTABILITIES
Testing and releasePlanning 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 new 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
Good Laboratory PracticePlanning 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 reagents & chemicals.
Rev