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Amneal India

Assistant Manager, QA Reviewer

Amneal India Ahmedabad, Gujarat, India

Pharmaceutical Manufacturing · 5,001-10,000 employees

7 h ago
qa Senior (5-10 yrs) Full-time India
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About the role

This role defines and specifies quality activities, processes, and standards to ensure compliance within a global pharmaceutical manufacturing environment. It involves reviewing quality documentation, managing in-process product quality, and troubleshooting manufacturing deviations to ensure timely delivery of compliant products.

What they look for

Quality Assurance GMP Guidelines 21 CFR Part 210 & 211 Batch Record Review Manufacturing Process Deviations Quality Documentation Regulatory Compliance Vendor Management Continuous Improvement Pharmaceutical Manufacturing Quality Infrastructure Troubleshooting Analytical Documentation Audit Trails Qualification Documents

Requirements

The position requires a Bachelor of Pharmacy degree, with a Master of Pharmacy preferred. Candidates must have 5 to 8 years of relevant experience in quality assurance within the pharmaceutical industry.

Full description

Description: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. It supports the review and evaluation of quality documentation, batch records, and manufacturing outputs against defined internal and regulatory standards. The role ensures efficient and effective workflows, procedures, policies, and review programs are in place and adhered to across manufacturing operations. It manages in-process product quality in coordination with vendors and contract manufacturers. The position facilitates communication with customers and vendors to resolve quality-related issues in a timely and compliant manner. It reports and troubleshoots manufacturing process deviations and defects identified in finished goods. The role contributes to continuous improvement initiatives aimed at reducing defects, errors, and rework across manufacturing operations. It also supports the identification and development of outsourcing vendors and suppliers according to organizational quality standards.

Essential Functions:• Define and specify quality activities, processes, and standards for quality review programs in compliance with regulatory requirements

  • Build and maintain quality infrastructure and systems to ensure timely delivery of compliant pharmaceutical products
  • Review and evaluate quality documentation, batch records, and manufacturing outputs against internal and regulatory standards including 21 CFR Part 210 & 211 and GMP guidelines
  • Ensure efficient workflow, procedures, policies, and review 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 review-related issues in a timely manner
  • Report and troubleshoot manufacturing process deviations and defects identified during quality review activities
  • Identify and implement process improvements to reduce costs, defects, errors, and rework in quality review and manufacturing operations
  • Support the identification and development of outsourcing vendors and suppliers according to organizational quality standards and policies

Additional Responsibilities:

Qualifications

Education:• B. Pharm B. Pharm - Required

  • M. Pharm M. Pharm - Preferred

Experience:• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

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