Assistant Manager - ADL

1) Analytical method development for raw material, Intermediate, API and finished products (preferably soft gelatin capsules) by HPLC, GC, Dissolution apparatus.
2) Review of analytical method validation / verification protocols and reports
3) Communication with R&D, RA, QA and QC department for to resolving method related queries.
4) Knowledge of method development in residual solvents as per ICH guidelines
5) Knowledge of separation techniques in chemical separation in chromatography in Normal and reversed phase systems
6) Preparation of Standard operating procedures (SOP) for all the instruments, equipment and procedures.
7) Execution of analytical method validation studies and reporting according to GMP
8) As a primary contact person for regulatory quarries and with External agencies and compliance matters of method validation
9) Handling of deviations and Laboratory incidents in timely basis