Senior Executive QA Validation

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals seeks a senior QA/Validation specialist to define and drive quality activities, validation programs, and standards across manufacturing operations in a global pharmaceutical environment. The role leads risk-based validation strategies, conducts audits, and monitors compliance with regulatory requirements such as GMP and 21 CFR.

You will coordinate with vendors and customers to resolve validation‑related issues and support continuous improvement across sites with

Qualifications

• 7+ years of experience in validation and quality systems.
• Bachelor of Pharmacy (B. Pharm) is required.
• Master of Pharmacy (M. Pharm) is preferred.

Responsibilities

• Define quality activities and validation programs.
• Lead risk-based validation strategies using quality risk management.
• Audit and monitor validation activities and manufacturing processes.
• Ensure compliant workflows, procedures, and validation documentation.

Skills

Quality assurance

Validation

Education

B. Pharm

M. Pharm

Job description

Job 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 auditing, monitoring, and evaluation of validation activities against defined internal and regulatory standards. The role ensures efficient and effective workflows, procedures, policies, and validation 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 and validation studies. The role contributes to continuous improvement initiatives aimed at reducing defects, errors, and rework across manufacturing operations. It also supports the development and maintenance of validation master plans and related documentation.

Essential Functions

• Define and specify quality activities, processes, and standards for validation programs in compliance with regulatory requirements
• Lead risk-based validation strategies using quality risk management principles to optimize validation efforts
• Build and maintain quality infrastructure and systems to ensure timely delivery of validated and compliant pharmaceutical products
• Conduct audits and monitoring of validation activities and manufacturing processes against internal and regulatory standards including 21 CFR Part 210 & 211 and GMP guidelines
• Ensure efficient workflow, procedures, policies, and validation inspection programs are implemented and maintained across manufacturing operations
• Manage in-process product quality and validation outcomes in coordination with vendors and contract manufacturers
• Communicate with customers and vendors to investigate and resolve quality and validation‑related issues in a timely manner
• Report and troubleshoot manufacturing process deviations and defects identified during validation studies and finished goods inspection
• Support the development and maintenance of validation master plans, protocols, and reports in accordance with regulatory requirements
• Identify and implement process improvements to reduce costs, defects, errors, and rework in validation and manufacturing operations

Qualifications

Education:

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 7 years or more in 7 - 8 Years

Specialized Knowledge: Licenses:

Requirements: