Head - QA/Drug Safety Risk Management

Roles & Responsibilities:

1. Internal Audit and Regulatory Inspections

a. Planning, Conducting system/process audits of subsidiaries, issuing audit reports, suggesting appropriate corrective and preventive action and audit closure

b. Leading and helping PV teams to prepare for regulatory inspections

c. Leading or participating on inspections teams with respect to hosting and responding to inspectors.

d. Serve as DSRM lead for conducting business partners PV audits.

2. Corrective Action and Preventive Action (CAPA)

a. Provide guidance to PV teams on preparations of CAPA, review inspection response for suitability and tracking adherence to CAPA

b. To conduct CAPA effectiveness verification

c. To facilitate ongoing quality improvement measures by communicating audit results and compliance

3. Standard Operating Procedures (SOP) and Training

a. Supporting PV team in planning SOP and regulatory training.

b. Developing induction plan for new hires and role based training plans.

c. Developing matrix to assess the impact of training programme.

4. Regulatory Compliance

a. Conduct and review gap analysis on new / existing PV regulations / guidances

b. Suggesting corrective actions for gaps with existing PV regulations / guidancesguidance/training.

c. Produce recommended plans for implementing new regulations

d. Creating and delivering training

e. Assist with other PV quality and compliance activities as required