Indian Business Unit

Job Purpose:

Effectively execute the action items for the
observations from internal audits, financial audits, regulatory audits of
Cipla, regulatory audits of other companies etc., across Cipla.

Daily Monitoring of life cycle management of
observations, action items, implementation of CAPA and sustenance of CAPA
across Cipla.

Escalate risks arising out of compliance to
top management in timely manner.

Accountability Cluster

Major Activities / Tasks

I.
Improve the system and process for implementation of Quality
compliance across Cipla sites.

* Identify the gaps in Quality
compliance implementation process and continuously improve the system.

* Process to receive the inputs (
internal audits, financial audits, regulatory audits etc.,) disseminate
across cipla units, effective implementation of action items, monitoring of
action items and ensure sustenance of previously implemented action items

II. Coordination and vigilant
monitoring

* Vigilant monitoring of action
items, CAPA across sites

* Coordinate with Site QA heads on
timely and effective implementation of action items

* Coordinate with internal audit
team, regulatory surveillance team on daily basis on 483s of other companies,
internal audit observations etc.,

* Coordinate with CFT members on
Quality compliance .

III.
Appraise top management on Quality compliance

* Appraise top management on daily
basis on risk of quality compliance.

* Escalate to top management on
critical issues in timely manne

Internal

External

* Internal audit team on internal audit observations

* Regulatory intelligence team on other companies 483s and new
regulations and guidance

* Site QAs for effective implementation of
actions

* Site Heads for effective implementation of
actions

* CQA SOP team for QA and QC SOP team

*

* Vendors through vendor quality team
and SCM on Quality compliance.