Head - Audit & Compliance (API)

Role & responsibilities

Quality Compliance Management

• Lead and maintain the site's GMP compliance program in alignment with regulatory requirements, corporate quality standards, and customer expectations.
• Ensure compliance with cGMP, Data Integrity and applicable regulatory guidelines.
• Monitor compliance trends and identify potential risks through periodic reviews and self-inspections.
• Drive continual improvement initiatives to strengthen the Quality Management System (QMS).

Regulatory Inspection Readiness

• Ensure continuous inspection readiness for USFDA, EDQM, MHRA, WHO, PMDA, TGA, and other regulatory inspections.
• Coordinate preparation activities for regulatory and customer audits.
• Lead audit management activities, including response preparation, CAPA tracking, and effectiveness verification.
• Conduct mock audits and gap assessments to evaluate site preparedness.

Quality Management System Oversight (Optional)

• Ensure timely closure and effectiveness of:

• Deviations

• OOS/OOT investigations

• CAPA

• Change Controls

• Market Complaints

• Supplier Quality Issues

• Risk Assessments

• Review compliance metrics and escalate critical issues to site leadership.

Data Integrity Governance

• Lead implementation and monitoring of Data Integrity programs across QC, QA, Manufacturing, Engineering, Warehouse, and computerized systems.
• Conduct periodic Data Integrity assessments and audits.
• Ensure compliance with ALCOA+ principles and computerized system controls

Internal Audit & Self-Inspection Program

• Establish and manage annual self-inspection schedules.
• Review audit observations, root cause investigations, and CAPA implementation.
• Monitor effectiveness of corrective and preventive actions.

Regulatory Intelligence and Compliance Monitoring

• Track changes in global regulatory requirements and industry trends.
• Assess impact and ensure timely implementation of new regulatory expectations.

Training and Quality Culture

• Promote a proactive quality and compliance culture across the organization.
• Develop annual GMP and Data Integrity training plans.
• Conduct awareness programs on regulatory expectations and inspection preparedness.
• Mentor teams on quality risk management and investigation excellence

Compliance Metrics and Management Review

• Develop and monitor site compliance KPIs, including:

• Audit observations

• CAPA closure timeliness

• Deviation closure performance

• Change control compliance

• Training compliance

• Data Integrity observations

• Customer complaints

• Present compliance trends and risk assessments during Management Review Meetings.

Preferred candidate profile

Qualification - M.Sc Chemistry
Experience: 15 to 18 years
Vertical or Division: API (Active Pharmaceutical Ingredients)

Having working experience in Audit & Compliance for Regulated Approved API Manufacturing Sites