Quality Assurance Manager

Company: SVR Drugs and Intermediates

Location: Kadechur, Karnataka

Experience: 15+ years in API / Bulk Drug Intermediate Manufacturing

Qualification: B.Pharm / M.Pharm / M.Sc. Chemistry or equivalent

Key Responsibilities
Establish and maintain a robust Quality Management System (QMS) and ensure GMP compliance.
Lead and surveillance audits and compliance improvement activities.
Drive US FDA regulatory readiness, GMP gap assessments and implementation of corrective actions.
Plan and lead internal audits, customer audits, supplier audits, certification audits and regulatory inspections.
Manage deviations, CAPA, change control, investigations, validation and document control.
Ensure data integrity, SOP compliance, batch record review and quality documentation.




Coordinate supplier qualification, customer audits, quality agreements and regulatory documentation.
Train employees on GMP, documentation practices and audit readiness.
Monitor quality KPIs and ensure timely closure of audit observations.

Candidate Requirements
Proven experience independently managing QA operations and leading audits.
Solid knowledge of ICH Q7, applicable GMP requirements, ISO 9001 and data integrity.
Hands-on experience in QMS implementation, regulatory inspection preparation and CAPA management.
US FDA inspection experience and ISO Lead Auditor certification preferred.

📌 Quality Assurance Manager Raichur (India)
🏢 SVR Drugs And Intermediates
📍 India