Officer

Job Description

1.To ensure timely Q.A. review of Q.C. documents and release of Raw material, In process samples, Finished product samples, Packing material samples, stability samples, Hold time, Cleaning validation/Verification samples as per production plan and dispatch schedule along with review of relevant analytical reports against specification.

2.Responsible for review of instrument and equipment qualification, calibration, working standard, volumetric solutions reports.

3.Responsible for review of analyst qualification reports.

4.Responsible for preparation and review of analytical COA, review of stability sample summary sheets and maintenance of Minitab trend data.

5.Q.A. review of Q.C. documents of relevant specification/ STP’s, and TDS & Analytical reports, sampling plans and validation protocols.

6.Usage decision for Raw material, In-process, finished product samples, Packing material samples, stability samples and inspection lots for instrument calibration.

7.To ensure online entry of instruments /timely updation of relevant logbooks and excess sample destruction.

8.To ensure availability and review SAP master plan for all raw material, In-process and finished product, packing material and stability samples.

Work Experience

3-6 yrs of Quality control experience 

Education

Competencies