Assistant Manager QA Inspection

The Assistant Manager QA Inspection will play a crucial role in supporting the Head of Quality Assurance by overseeing in-process and inspection checks throughout production operations and facilities. This position ensures strict adherence to Abbott policies, AQ, EQDs, SOPs, GMP, and the Drug Act. Responsibilities include conducting area GEMBA inspections to maintain inspection readiness, reviewing logbooks and documentation with a strong emphasis on data integrity, and sampling bulk, intermediate, and finished products. The role is based in Karachi within a well-established pharmaceutical division and requires close collaboration with production teams to uphold quality standards.

Key Responsibilities
Manage activities within the assigned section to prevent production delays and ensure product availability. Conduct line clearance and in-process checks during manufacturing and finishing operations to maintain compliance and quality. Perform GEMBA inspections of warehouses, utilities, and facilities in line with Abbott policies, GMP, and regulatory guidelines. Sample intermediate, bulk, finished, and stability products to verify quality standards are met. Maintain and improve existing quality processes to ensure compliant operations in production and storage areas. Write, revise, and implement SOPs in accordance with AQ, EQDs, SOPs, the Drug Act, and cGMP requirements. Plan daily activities, provide training, and effectively manage QA Inspectors to optimize team performance. Ensure all documentation is accurate, timely, and compliant with data integrity and regulatory standards. Oversee calibration and verification of in-process equipment and instruments to guarantee operational accuracy. Participate in validation and qualification activities related to processes, equipment, and facilities as required. Assist the Head of QA in data collection and preparation of quality metrics and quarterly trend reports. Audit batch documents, manage disposition of finished products, and follow up on corrective actions within the area of responsibility. Actively handle exception reports, internal quality investigations, and customer complaints by identifying root causes and implementing corrective and preventive actions (CAPA). Train newly inducted QA Inspectors on QA processes and procedures within production areas. Ensure workplace compliance with health and safety regulations, report safety incidents or near misses, and follow through until resolution. Manage drug inspector samples and serve as the training coordinator for QA Inspection activities.

Required Qualifications
A science graduate or master’s degree, preferably in Chemistry or Pharm D. A minimum of 3-4 years of experience in a similar QA inspection role within the pharmaceutical industry. Strong knowledge of QA documentation, technical problem resolution, and QA operational activities. Proficiency in MS Office applications. Excellent analytical and problem-solving skills.

This position offers an excellent opportunity to contribute to a reputable pharmaceutical division, ensuring high-quality standards and regulatory compliance in a dynamic production environment. The role demands attention to detail, leadership in managing QA Inspectors, and a proactive approach to maintaining inspection readiness and quality assurance processes.