Responsibilities
1.Review of relevant standard operating procedures to check compliance with the guidelines and suggest appropriate modification if any.
2.Reporting to Senior Manage/ Assistant Manager on all activities related to the Clinical quality assurance department.
3.Conducting training on concerned standard operating procedures and good clinical practices along with other personnel from different departments and within the department.
4.Check for compliance of study related activities to good clinical practice, concerned standard operating procedures and protocol.
5.Maintain obsolete clinical and medical diagnostic service standard operating procedures, and working documents relating to the same departments.
6.Verification and review of all bioequivalence/bioavailability study reports.
7.Preparation/ review of standard operating procedures related to clinical quality assurance.
8.Conducting facility and quality system audits.
9.Review of documents to ensure compliance with respect to validation and calibration of clinical instruments and software as per standard operating procedure and validation master plan.
10.Sign a statement declaring that the study has been conducted according to good clinical practice /concerned standard operating procedures, wherever appropriate.
11.To maintain computer system for electronic distributions.
12.Periodic check of log books.
13.Issue of log books & forms and maintaining inventory of log books.
14.To check the log book format with the approved log book template, maintain master and obsolete copies of the log book templates.
15.Verification of standard operating procedures maintained on computer system for electronic distribution/access
16.Review of temperature and humidity records
17.Verification of system compliance of the system with respect to the standard operating procedures and other applicable regulatory requirements and to the response to the queries.
18.To carry out other responsibilities as and when assigned by the management.
Qualifications
Skills, experience, education
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