Deputy General Manager, Quality Control

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks a Lead Quality Control professional to oversee analytical, microbiological, and stability testing across QC operations in Ahmedabad SEZ. You will ensure cGMP compliance, review data trends, and drive CAPA and investigations to maintain quality standards.

You will manage instrument qualification, method validation, and stability programs while leading audits and readiness for internal, customer, and regulatory inspections.

Qualifications

• B. Pharm / B. Pharm required.
• M. Pharm preferred.
• 15+ years of quality control experience in pharma.

Responsibilities

• Lead QC laboratory operations across analytical, microbiological, and stability testing.
• Ensure cGMP compliance and global regulatory standards for QC activities.
• Oversee review, approval, and trending of analytical and microbiological data.
• Govern OOS, OOT, deviations, investigations, and CAPA implementation.
• Ensure effective instrument qualification (IQ/OQ/PQ), calibration, and maintenance.
• Drive analytical method validation, verification, and transfer.
• Oversee stability programs, shelf-life determination, and data review.
• Lead audit and inspection readiness for internal, customer, and regulatory audits.
• Manage supplier, material, and vendor quality testing and qualification.
• Ensure data integrity, documentation control, and electronic system compliance.
• Monitor QC performance metrics and continuous improvement initiatives.
• Train, mentor, and develop QC teams and technical capabilities.
• Review and approve SOPs, STPs, Specifications, Protocols, and Reports.
• Implement laboratory efficiency improvement initiatives.

Skills

Corrective & Preventive Action

Cross-functional Collaboration

GMP & Regulatory Oversight

Audit Management

OOS Analysis

Quality Assurance

QMS Administration

Quality Risk Analysis

Stakeholder Management

Strategic Implementation

Validation & Qualification

Education

B.Pharm / B.Pharm

M.Pharm

Job description

• Lead Quality Control laboratory operations including analytical, microbiological, and stability testing


• Ensure compliance with cGMP and global regulatory standards for QC activities


• Oversee review, approval, and trending of analytical and microbiological data


• Govern OOS, OOT, deviations, investigations, and CAPA implementation


• Ensure effective instrument qualification (IQ/OQ/PQ), calibration, and maintenance


• Drive analytical method validation, verification, and transfer


• Oversee stability programs, shelf-life determination, and data review


• Lead audit and inspection readiness for internal, customer, and regulatory audits


• Manage supplier, material, and vendor quality testing and qualification


• Ensure data integrity, documentation control, and electronic system compliance


• Monitor QC performance metrics and continuous improvement initiatives


• Train, mentor, and develop QC teams and technical capabilities


• Review and approve SOPs, STPs, Specifications, Protocols, and Reports


• Implement laboratory efficiency improvement initiatives

Qualifications

Education:

• B. Pharm B. Pharm - Required


• M. Pharm M. Pharm - Preferred

Experience:

• 15 years or more in 15+ Years

Specialized Knowledge:

Licenses:

Required Skills

• Corrective & Preventive Action Management


• Cross-functional Collaboration


• GMP & Regulatory Compliance Oversight


• Internal & External Audit Management


• OOS Results Review & Analysis


• Quality Control & Compliance Assurance


• Quality Management System Administration


• Quality Risk Analysis & Control


• Stakeholder Management


• Strategic Planning & Implementation


• Validation & Qualification Oversight

Job Info

• Job Identification 9491


• Job Category Quality Control


• Locations Plot No.- 15,16,17, Pharmez Special Economic Zone (SEZ)|, Ahmedabad, GJ, 382110, IN