General Manager Quality Control

1. Quality Control Leadership

• Lead and manage end-to-end QC operations covering raw materials, in-process, finished products, stability studies, and microbiological testing.
• Establish and implement QC strategies aligned with business goals, regulatory requirements, and global quality standards.
• Ensure timely release of materials and finished goods without compromising quality.

2. Regulatory Compliance & Audits

• Ensure compliance with FSSAI regulations, Schedule IV GMP, USFDA 21 CFR Part 111, and applicable international standards.
• Lead and manage regulatory inspections, customer audits, and third-party audits related to QC.
• Review and approve responses to audit observations, deviations, OOS/OOT, CAPA, and change controls.

3. Analytical & Laboratory Excellence

• Approve analytical methods, method validation/verification, and method transfer activities.
• Oversee calibration, qualification (IQ/OQ/PQ), and maintenance of QC instruments and laboratory infrastructure.
• Ensure integrity and accuracy of laboratory data in line with ALCOA+ principles.

4. Stability & Product Quality Management

• Oversee stability programs as per ICH guidelines and nutraceutical regulatory requirements.
• Ensure scientifically sound shelf-life assignment and trend analysis.
• Monitor product quality trends and initiate continuous improvement actions.

5. Documentation & Quality Systems

• Ensure preparation, review, and approval of SOPs, specifications, STPs, COAs, and quality reports.
• Strengthen documentation practices, data governance, and electronic systems (LIMS, CDS, ERP).
• Ensure compliance with data integrity and record retention requirements.

6. Team Leadership & Capability Building

• Build, mentor, and develop a high-performing QC team.
• Drive training programs on GMP, GLP, data integrity, and regulatory compliance.
• Conduct performance reviews and succession planning for QC leadership.

7. Cross-Functional & Business Support

• Collaborate with QA, R&D, Production, Regulatory Affairs, Procurement, and Supply Chain teams.
• Provide QC inputs for new product development, scale-up, technology transfer, and vendor qualification.
• Support regulatory submissions, export registrations, and customer technical requirements.

8. Continuous Improvement & Cost Optimization

• Drive laboratory efficiency, right-first-time testing, and reduction in OOS/OOT trends.
• Implement automation, digitization, and best practices in QC operations.
• Optimize laboratory costs without compromising quality or compliance.