Assistant Manager I&D QA in Bombay, भारत

Abbott seeks an Assistant Manager for Injection & Infusion Drug Product Quality Assurance in Mumbai. The role involves overseeing quality compliance, process improvements, and regulatory adherence across pharmaceutical development and manufacturing activities.

Responsibilities

• Support quality oversight for EPD drug product development projects and processes
• Prepare, review, and approve standard operating procedures and quality documentation
• Review and approve change controls, exceptions, and out-of-specification investigations
• Manage internal audit programs and ensure ongoing compliance with applicable policies
• Collate quality metrics, prepare monthly reports, and track CAPA implementation

Requirements

• 9 years of experience in pharmaceutical quality assurance or related field
• Knowledge of quality management systems and regulatory compliance frameworks
• Experience with SOP development, change control, and deviation management
• Familiarity with internal audit programs and CAPA processes
• Understanding of pharmaceutical manufacturing and drug product development