QC Head (API)

Roles & Responsibilities:
• Ensure supply of high-quality, ICH Q7-compliant APIs / bulk drug substances
• Define and implement QC operational strategy aligned with regulatory and corporate quality objectives
• Oversee release of raw materials, intermediates, in-process samples, and APIs
• Monitor API stability programs as per regulatory commitments
• Ensure analytical method validation and transfer as per ICH Q2 and API requirements
• Review investigations, QMS, and implement effective CAPA to minimize compliance risks
• Ensure SOP, policy, and quality system compliance across QC functions
• Drive continuous improvement initiatives to enhance compliance, efficiency, and cost effectiveness
• Maintain inspection readiness for regulatory audits and internal assessments
• Oversee impurity profiling (including genotoxic impurities), residual solvent testing (ICH Q3C), particle size distribution, and API quality attributes
• Manage QC budgets, capital planning, and headcount projections
• Ensure collaboration across Sun Pharma sites and align with global quality policies
• Provide leadership, performance management, and team development to QC staff

Qualification:
• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

Experience:
• 18+ years of experience in Quality Control within API manufacturing

Skills:
• Strong knowledge of ICH Q7, ICH Q2, ICH Q3C, and GMP regulations
• Expertise in API quality control operations and analytical compliance
• Experience in regulatory inspections and audit management
• Strong leadership and team development capabilities
• Budgeting, resource planning, and operational excellence mindset
• CAPA management and QMS oversight expertise
• Cross-functional collaboration and stakeholder management

About the Organization:
Sun Pharmaceutical Industries Ltd is a leading global specialty generic pharmaceutical company with a strong presence in APIs and finished dosage forms. The organization is committed to regulatory excellence, innovation, and delivering high-quality medicines worldwide while fostering leadership and continuous growth.