Plant Quality

OmniActive Health Technologies; Pune District; On-site; INR 2,000,000 - 3,000,000; Full time

Job summary

OmniActive Health Technologies is seeking a Quality Assurance (QA) and Quality Control (QC) lead in Pune District, India. This position focuses on ensuring compliance with global regulatory standards and enhancing product quality through a robust Quality Management System. Ideal candidates will have over 15 years of experience in the pharma or nutraceutical industry, along with strong expertise in handling audits and implementing quality systems. This role emphasizes stakeholder collaboration and continuous improvement in operational efficiency.

Qualifications

• 15+ years of relevant experience in QA & QC within pharma or nutraceutical industry.
• Proven experience in handling global regulatory and certification audits.
• Strong expertise in Quality Management Systems (QMS).
• Hands-on experience with advanced QC instrumentation and analytical techniques.
• In-depth understanding of regulatory frameworks: US FDA, EU GMP.

Responsibilities

• Lead and manage end-to-end QA & QC operations at the plant.
• Ensure all raw materials and finished goods meet defined specifications.
• Ensure readiness for regulatory audits (US FDA, EU GMP).
• Drive continuous improvement initiatives to enhance product quality.

Skills

Quality Management Systems (QMS)

Regulatory compliance (US FDA, EU GMP)

Troubleshooting and problem-solving

Stakeholder management

Team development

Tools

SAP

Advanced QC instrumentation

Job description

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)
• 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

• 15+ years of relevant experience in QA & QC within pharma or nutraceutical industry
• Proven experience in handling global regulatory and certification audits
• 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