Head - Audit & Compliance (API)

Search Advisers Services Guj; Ankleshwar; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Search Advisers Services Guj seeks a senior Quality & Compliance Manager to lead GMP programs, ensure cGMP and data integrity, and drive regulatory inspection readiness for API manufacturing. You will coordinate audits, CAPA, and QMS improvements, fostering a proactive quality culture across QC, QA, and manufacturing teams.

The role requires extensive experience in regulated pharma settings, strong regulatory knowledge, and leadership to sustain inspection readiness and continual improvement

Qualifications

• 15 to 18 years of experience in quality/compliance roles within API manufacturing or regulated pharma environments.
• Proven track record in GMP compliance, regulatory inspections readiness (USFDA, MHRA, WHO, etc.), and audits.
• Strong understanding of Data Integrity principles (ALCOA+) and CAPA management.

Responsibilities

• Lead and maintain the site's GMP compliance program aligned with regulatory requirements and customer expectations.
• Ensure cGMP compliance, data integrity and adherence to applicable regulatory guidelines.
• Monitor compliance trends, perform self-inspections, and drive continual improvement of the QMS.
• Coordinate regulatory inspections readiness and audit activities, including CAPA tracking and effectiveness verification.
• Oversee Data Integrity governance across QC, QA, Manufacturing, and systems.
• Develop and monitor compliance metrics and management reviews; promote quality culture.

Skills

GMP Compliance

Regulatory Compliance

Audits & CAPA

Data Integrity

QMS Oversight

Training & Quality Culture

Education

M.Sc Chemistry

Job description

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 elevate 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