Sampling & Sample management:
- Sampling of Raw Material, intermediate and as per the relevant SOP's
- Ensure proper storage as per Storage conditions for Raw Material, intermediate, stability samples and Finish Product as per the relevant SOP's
Analysis:
- Analysis of Raw Materials, stability samples, finished goods as per the required specifications on time.
- Ensure cGLP in the laboratory activities.
- Carry out instrumental analysis of stability samples, Raw materials, Finished Goods such as HPLC, GC, Dissolution, potentiometer, IR spectrophotometer, Raman Analyzer, Dissolution tester, Disintegration tester, Viscometer, Tap density apparatus, Microscope, UV-Vis Spectrophotometer, Conductivity meter, pH Meter, Sieve shaker, Melting point etc.
Documentation:
- Prepare and maintain raw data and analytical records in compliance with the current regulatory requirements.
- Maintain the raw data as per regulatory requirements.
- Scanning and Proper Storage of Raw Material ATR in documentation store.
- Filling and documentation of ILI/Deviations at site.
- Review of logbooks, Calibration records, Qualification documents etc.
- Review and revise the specifications and test procedures based on the pharmacopeia
- Raising deviations and implementation of CAPAs through PHENIX
- Carry out result recording, Review of data, printing of ATRs, Sampling instruction transactions in SAP ATHENA
- Perform qualification of new instruments.
- HPLC trouble shooting
Qualification/Calibration/Validation:
- Carry out the calibrations and preventive maintenance of instruments as per SOP and maintain records.
- Perform qualification of instruments
- Carry out the validation of analytical methods as per the testing procedure
Pursue
progress, discover
extraordinary
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