To adhere to procedures on cGMP and GLP and relevant ISO procedures that guide all quality control processes.
Conduct quality control tests on water, bulk, raw materials stability samples and finished products.
Document and prepare reports for all Quality control activities performed online; calibrate and Maintain laboratory equipment as per the plan
Interpret all documents in QC process, revise and prepare SOPs and COAs as required in the process
Work effectively with other analysts and team leaders to achieve shared goals and meet timelines for batch processing and filling processes.
Participate in OOS, OOT investigation, deviation handling, change control, CAPA closure, and quality risk management for continuous improvement.
Participate in training, knowledge sharing, and transfer activities for efficiency and competency.
Sampling of RM, FP, preparation of reagent & standardization of reagent as per production plan requirements.
Calibration of new glassware.
Working standard preparation.
Handling & maintaining Reference standard as per reference standard SOPs, preparation of working standard.
Perform analysis for intermediate sample, finished product sample, Raw material sample, stability sample, PPM & SPM as per work plan ensure it will meet with specification
Perform method validation & verification for the new method and establish specifications.
Proper use and handling of chemicals and consumables
Perform online reporting & keep records.
Timely and proper Communication with staff at all levels while making critical escalation on time
Use provided personal protective gear appropriately.
Proper communication and handling and investigation of all incidences, near misses and accidents