The incumbent will be responsible for
1. Ensure that all the incoming material as well as the material produced in the site is analysed for its quality attributes correctly.
2. Ensure that the cGMP practices are followed correctly in the Quality control department.
3. Review of all analytical data generated in Quality Control for raw materials, intermediates, API
4. Review of all documents prepared in the Quality Control including Standard operating procedures, instrument operating procedure.
5. To ensure stability study samples are charged as per predefined time
6. To coordinate analytical transfer activities for various projects
7. Ensuring training of associates to perform their jobs as per cGMP
8. To check and approve all the qualification document and Calibration document
M.Sc. with similar experience in a reputed preferably MNCs pharma company manufacturing API.
The candidate must have
a)Good analytical skills.
b) Good understanding of Chromatographic techniques.
c) Good understanding of GMP requirements for Quality Control.
d) Good document preparation knowledge as per GMP requirements.
e)Good understanding of various regulatory requirements Skills