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Assistant General Manager, Quality Assurance at Amneal India

Visakhapatnam, Andhra Pradesh, India -

Full Time

Start Date

Immediate

Expiry Date

06 Aug, 26

Salary

0.0

Posted On

08 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP, ICH Guidelines, Quality Systems, Validation, Compliance, API Manufacturing QA, Analytical Skills, Problem-solving, Leadership, Team Management, Audit Handling, Documentation, Communication Skills

Industry

Pharmaceutical Manufacturing

Description

Job Description : “The AGM – Quality Assurance is responsible for leading and ensuring compliance of all quality systems in API manufacturing, including documentation control, change management, validation, vendor qualification, batch release, regulatory coordination, deviation/CAPA management, and overall adherence to cGMP and customer requirements.” Key Responsibilities: 1. Quality Systems & Documentation 2. Change Control Management 3. Vendor & Contract Management 4. Validation & Qualification 5. Batch Release & Compliance 6 Deviation, CAPA & Investigation 7. Technology Transfer 8. Customer & Regulatory Interfac 9. Product Quality & Complaints Handling 10.Quality Monitoring & Governance Key Skills & Competencies * Strong knowledge of cGMP, ICH, and regulatory guidelines * Expertise in Quality Systems, Validation, and Compliance * Hands-on experience in API manufacturing QA * Strong analytical and problem-solving skills * Leadership and team management abilities * Audit handling (Regulatory & Customer) * Excellent documentation and communication skills

Responsibilities

The AGM of Quality Assurance leads and ensures compliance of all quality systems in API manufacturing. This includes managing documentation, change control, validation, batch release, and regulatory coordination.