1.

To follow SOP on
“Central
Quality – Audit and Compliance”.

2.

To follow CAC
monthly schedule for audit execution activity at identified sites and support
functions.

3.

To plan &
execute additional audits/review based on management need and guidance.

4.

To prepare and
review audit agenda based on site performance and expected regulatory
inspection at site.

5.

To ensure execution
of Corporate Quality Audit for quality systems as per SOP.

6.

Participate in
audit opening and closing meetings. To discuss audit observations with site
leadership.

7.

To ensure
holistic compliance need/expectations for the CAC/Regulatory/GMP consultant
audit findings.

8.

Apprise the audit
outcome to Head Technical Services, Head Central Quality and Head CAC prior
to submit final report.

9.

To categorize
citations and submission of final report in Audit portal as per SOP

10.

To prepare
executive summary of audit for management escalation.

11.

Timely
submission of audit reports and review response to audit observations as per
SOP.

12.

To ensure compliance
verification of identified CAC/External SME/regulatory CAPA for adequacy
during periodic or verification audits and off-site review, as applicable.
Report compliance status during periodic departmental & management
review.

13.

To assist site
for readiness during regulatory or GMP consultant inspections, as needed.

14.

To review the
draft response for adequacy prior to submission to regulatory/SME agency.

15.

Preparation of
compliance reports periodically for the respective sites for management
review.

16.

To participate in
the departmental and management review meetings for escalation of specific
issue for compliance and support.

17.

To participate in
Central Quality Policy preparation, review and implementation.

18.

Update self with current regulatory guidance/GMP trends, current industry
knowledge regarding the system and provide required inputs for strengthening the audit
plan.

19.

To prepare and
review departmental SOPs.

20.

To maintain repository of regulatory documents (report, response,
& certificates) in portal and update the status in
departmental/management review meetings.

21.

System harmonization-Identification of need & escalation.

22.

Participation in development of new initiatives as needed.