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 a 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 processes and continuously improve the system.

• Establish a process to receive inputs (internal audits, financial audits, regulatory audits, etc.), disseminate them across Cipla units, ensure effective implementation of action items, monitor the action items, and ensure sustenance of previously implemented action items.

II. Coordination and Vigilant Monitoring

• Vigilant monitoring of action items and CAPA across sites.

• Coordinate with Site QA Heads for timely and effective implementation of action items.

• Coordinate with the internal audit team and regulatory surveillance team on a daily basis regarding 483s of other companies, internal audit observations, etc.

• Coordinate with CFT members on Quality compliance.

III. Appraise Top Management on Quality Compliance

• Provide daily updates to top management regarding risks in Quality compliance.

• Escalate critical issues to top management in a timely manner.

Key Stakeholders:

Internal:

• Internal Audit Team (on internal audit observations)

• Regulatory Intelligence Team (on other companies’ 483s and new regulations/guidance)

• Site QA teams (for effective implementation of actions)

• Site Heads (for effective implementation of actions)

• CQA SOP Team (for QA and QC SOPs)

External:

• Vendors (through Vendor Quality Team and SCM on Quality compliance)