Areas of Responsibility

Job 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.

Educational Qualification: B.Sc /M.SC / B.Pharm
Experience: 8 to 10 Years of experience See Less