Senior Executive, Quality Assurance

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad is looking for a Quality Manager to oversee quality activities for manufactured products. The ideal candidate will define quality standards, conduct audits, and manage process quality in compliance with regulations.

The role requires a B. Pharm degree and at least 5 years of experience in quality management within the pharmaceutical industry. The position offers opportunities for process improvement and collaboration with various stakeholders.

Qualifications

• 5+ years in quality management in the pharmaceutical industry.
• Experienced in compliance with regulatory standards.

Responsibilities

• Define quality processes for manufactured materials and products.
• Conduct audits of manufacturing processes.
• Manage in-process product quality.

Skills

Quality management

Regulatory compliance

Process improvement

Auditing

Education

B. Pharm

M. Pharm

Job description

Job Overview

This role is responsible for defining and specifying the activities, processes, and standards required to fulfill quality requirements for manufactured materials, components, and products within a global pharmaceutical environment. The position builds and maintains the infrastructure and systems necessary to consistently ensure the timely delivery of quality‑compliant products.

Key Responsibilities

• Define and specify quality activities, processes, and standards for manufactured materials, components, and products in compliance with regulatory requirements.
• Build and maintain quality infrastructure and systems to ensure timely delivery of compliant pharmaceutical products.
• Conduct audits and monitoring of manufacturing processes and outputs against internal and regulatory standards, including 21 CFR Part 210 & 211 and GMP guidelines.
• Ensure efficient workflow, procedures, policies, and inspection programs are implemented and maintained across manufacturing operations.
• Manage in‑process product quality in coordination with vendors and contract manufacturers to meet defined quality specifications.
• Communicate with customers and vendors to investigate and resolve quality‑related issues in a timely manner.
• Report and troubleshoot manufacturing process deviations and defects identified in finished goods.
• Identify and implement process improvements to reduce costs, defects, errors, and rework in manufacturing operations.
• Support the identification and development of outsourcing vendors and suppliers according to organizational quality standards and policies.

Education

• B. Pharm – Required
• M. Pharm – Preferred

Experience

• 5 or more years of experience in quality management within the pharmaceutical industry (5–8 years preferred).

Specialized Knowledge & Licenses

None specified.