Indian Business Unit -Cipla Vista Trade
Company: Cipla USA
Location: Warren
Posted on: November 20, 2024
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Job Description:
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 ClusterMajor 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
InternalExternal* 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.
Keywords: Cipla USA, Hoboken , Indian Business Unit -Cipla Vista Trade, Other , Warren, New Jersey
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