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Quality

• To adhere to procedures on cGMP and GLP and relevant ISO procedures that guide all Q.C. processes.
• Conduct quality control tests on water, bulk, raw material stability samples, and finished products.
• Document and prepare reports for all QC activities performed online, and calibrate and maintain laboratory equipment as per the plan.

Technical Work

• 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 process.
• 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 glassware of new glassware’s.
• Working on standard preparation.
• Handling & maintaining the reference standard as per the reference standard SOPs and preparation of the 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 the specification
• Perform method validation & verification for the new method and establish specifications.
• Proper use and handling of chemicals and consumables

Reporting & Communication

• Perform online reporting & keep records.
• Timely and proper communication with staff at all levels while making critical escalations on time.

Safety

• Use provided personal protective gear appropriately.
• Proper communication and handling and investigation of all incidents, near misses and accidents

Authorities:

• Chemical analysis of all types of samples.
• Signing work reports.
• Request reports & logbooks.
• Release intermediate samples.
• Request for chemicals & glassware.