Medical Device Quality Control|Kairish Innotech Pvt Ltd|Daman

Role & responsibilities

1)Ensure quality inspection in every stage as per SOP or define protocol.

2)Coordinate with R&D & QA for development & review of analytical process & specifications.

3)To coordinate with testing & calibration agency.

4)Maintain quality control records, calibration activity records, control samples records.

5)To establish guidelines/procedures depending on cGMP & GLP,SOP of overall QC activities .

6)Authorized for testing & analysis of validations/qualifications samples.

7)Protocols & records related to methods/process/cleaning/testing methods/calibration etc.

8)Investigation support for change in process or parameter

9)Scheduled calibration of functioning tools, instruments & equipment used, verification

10)Scheduled calibration of functioning tools, instruments & equipment used, verifications

11)Analysis of return products

12) Preparation of working quality standards with respect to reference standards.

13)Stability testing & evaluation of self life