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JOB ROLES AND EXPECTATIONS:

Key Result Area

Key Roles / Duties

Quality

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

Technical Work

1. Interpret all documents in QC process and revise and prepare SOPs and COAs as required in the process
2. Work effectively with other analysts and team leaders to achieve shared goals and meet timelines for batch processing and filling processes.
3. Participate in OOS, OOT investigation, deviation handling, change control, CAPA closure, and quality risk management for continuous improvement.
4. Participate in training, knowledge sharing, and transfer activities for efficiency and competency.
5. Sampling of RM, FP, preparation of reagent & standardization of reagent per production plan requirements.
6. Calibration of glassware of new glassware’s.
7. Working standard preparation.
8. Handling & maintaining reference standards as per reference standard SOPs, preparation of working standard.
9. Perform analysis for intermediate sample, finished product sample, Raw material sample, stability sample, PPM & SPM as per work plan ensure it will meet with specifications.
10. Perform method validation & verification for new method and establish specifications.
11. Proper use and handling of chemicals and consumables

Reporting & Communication

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

Safety

1. Use provided personal protective gears appropriately.
2. Proper communication and handling and investigation of all incidences, near misses and accidents

AUTHORITIES:

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