Plant Quality

Job Purpose and Scope:

Incumbent is responsible for leading the Quality Assurance (QA) and Quality Control (QC) functions at the plant, ensuring adherence to global regulatory standards and building a robust Quality Management System (QMS). The role focuses on ensuring audit readiness, driving quality excellence, and positioning quality as a key differentiator for the organization. The incumbent will work closely with cross-functional stakeholders to ensure consistent product quality, compliance, and continuous improvement across operations.

Key Accountabilities:

Strategic

Formulate and implement a robust Quality Management System (QMS) aligned with global regulatory and certification standards

Drive quality as a competitive advantage and enable customer delight

Build long-term capability and roadmap for plant quality excellence

Operational

Lead and manage end-to-end QA & QC operations at the plant Plan and oversee laboratory activities and plant QA processes

Ensure all raw materials, intermediates, and finished goods meet defined specifications

Ensure readiness for regulatory audits (US FDA, EU GMP) and certification audits (GFSI, BRC, FSSC 22000, NSF GMP)

Conduct internal audits and ensure adherence to quality systems and procedures Develop, qualify, and manage third-party laboratories (3P labs)

Collaborate with cross-functional teams including manufacturing, supply chain, and agri-QC

Ensure compliance with food safety standards (HACCP, 21 CFR Part 117, FSSAI)

Developmental / Continuous Improvement

Identify and implement improvement opportunities through advanced technologies, better processes, and best practices

Drive continuous improvement initiatives to enhance product quality and operational efficiency

Monitor QMS effectiveness through periodic reviews and recommend corrective actions

Build capability within QA/QC teams through structured training and certification programs

Promote a strong culture of quality, compliance, and innovation

Qualifications, Experience & Skills

Education:

M.Sc. (Chemistry) / M. Pharm / B. Pharm

Experience:

15+ years of relevant experience in QA & QC within pharma or nutraceutical industry

Proven experience in handling global regulatory and certification audits

Skills & Competencies:

Strong expertise in Quality Management Systems (QMS)

Hands-on experience with advanced QC instrumentation and analytical techniques

Strong troubleshooting and problem-solving capability Knowledge of SAP and digital quality systems

In-depth understanding of regulatory frameworks: US FDA, EU GMP

Knowledge of food safety and compliance standards: HACCP, 21 CFR Part 117, FSSAI

Strong leadership, stakeholder management, and team development skills