Shriram Institute Of Industrial Research - Head - Quality Assurance

Job Description :

1. Head QA directly reports to the management and is familiar with the test procedures of the facility.

2. The responsibilities of the Head, QAU includes:

a) He has direct access to the Master Schedule.

b) Maintaining all the copies of approved study plan and standard operating procedures in use in the facility.

c) To verify that the study plan contains information required for compliance with the Principle of GLP. This verification should be documented. To conduct the inspections so as to determine that all the studies are conducted in with principles of GLP.

e) To monitor that the study plans and standard operating procedures are made available to the study personnel and are being followed.

f) Promptly reporting the inspection results in writing to management, study director/Auditee and principal investigator (if any).

g) To keep the record of all the inspections.

h) Inspect the final report to confirm that the method, procedures and observations are accurately and completely described. The reported results accurately and completely reflects the raw data of study.

i) Preparing and signing a QA statement to be included in the final report which specifies types of inspections and their dates including the various phases of the study and the dates of inspections, results reported to the management and study director. This statement would also serve to confirm that final report reflects the raw data.

Key Skills - toxicology, quality assurance, glp