Deputy General Manager Quality Control

Amneal Pharmaceuticals; Ahmedabad District; Presencial; INR 2.000.000 - 4.200.000; Tempo integral

Resumo da vaga

Amneal Pharmaceuticals LLC is seeking a senior leader for Quality Control, overseeing analytical, microbiological, and stability testing across the QC lab. You will ensure cGMP compliance, data integrity, and drive continuous improvement while guiding auditors and regulatory inspections.

The role requires a Pharm degree (B.Pharm) with 15+ years in QC, and a preference for M.Pharm. Strong leadership and expertise in instrument qualification, method validation, and CAPA are essential.

Qualificações

• Bachelor’s degree in Pharmacy (B.Pharm) is required.
• Master’s degree in Pharmacy (M.Pharm) is preferred for advanced qualification.
• Minimum 15+ years of experience in QC roles and leadership.

Responsabilidades

• 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

Conhecimentos

QC leadership

Analytical testing

Regulatory compliance

Data integrity

Method validation

Formação

B. Pharm / B.Pharm - Required

M. Pharm - Preferred

Descrição da vaga

Job Description:

Essential Functions

• 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

Additional Responsibilities

QUALIFICATIONS

Education

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

Experience:

• 15 years or more in 15+ Years

Specialized Knowledge:

Licenses:

Requirements: