AddressJob Responsibilities:
- To have thorough knowledge and understanding of QC workflows (Analysis/ Review/ Approve/ Investigation etc.), Analytical methods (Instrumental/ Pharmacopoeial chapters/ Monographs), QC instrumentation activities (operation, calibration, preventive maintenance etc.) and Analytical method validation/Method transfer activities and other processes of QC.
- To have thorough knowledge and understanding of Analysis reporting requirements of all stages of product for eg, but not limited to; Finished product, API, Excipients, Process validation, Hold time, Swab/rinse samples, Stability including result reporting, trending, COA requirements etc.
- To support for timely execution and completion of Masterdata activities.
- To ensure Masterdata creation and review as per established procedures and ensure updation of masterdata as per the observations, if any.
- To list down observations for any discrepancies found during creation/review of masterdata and share to respective team for resolution.
- To handover reviewed Masterdata for further process and keep track of closure of observations, if any.
- To track Masterdata activity status for creation, review and observation closure etc.
- To coordinate masterdata change management to ensure ongoing compliance with business and regulatory requirements.
- To have good hands on MS office (i.e. Word / Excel / Power Point) and other computer skills.
