Back to jobsTo adhere with the cGMP principles and to maintain them in an effective manner.
Responsible to carry-out chemical and physical analysis of FP/RM/Stability, process validation
Responsible for the operation of various QC equipment (depending on the section)
Prepare to follow GLP, GMP and safety procedures and maintain hygienic conditions in lab
Entering data on SAP.
Responsible for recording all working data.
Helps supervisors in assigned tasks
To ensure and follow GLP, GMP, safety procedures and maintain hygienic conditions in lab.
Training newly joined staff
Entering and checking data of analyst on SAP
Assist in trouble shooting and solving problems that may come up in the day-to-day operation of the department.
Ensure Final Products adhere to all specifications and regulations.
Create HPLC & GC analytical methods from approved STM/Pharmacopeia for all analysts before starting analysis
Processing and approval for all HPLC &GC analytical data for all analysts, review and check all the Audit trial for all the instruments.
To train the QC personnel on all the applicable procedures, specifications, testing methods and qualify analysts to perform various QC analysis.
To ensure the analysis is performed correctly as per applicable procedures
To perform investigation for the lab incidents, OOS, OOT results, deviations and take appropriate corrective and preventive actions.
To lock the results in SAP, to create notifications & reservations for maintaining enough stock of chemicals & consumables.
To involve and support external and internal audits and to close the audit observations on time.
Review and approve protocols and reports such as method validation, method transfer, process validation and stability.
To handle and close the Quality management system actions like Deviations, OOS, CAPAs, AMS and Change controls using Amplelogic system.
To follow and ensure data integrity and good documentation practices are implemented in the QC labs.
Apart from the above, the works assigned by the Head of the department/designee.