Our client, a Big4 consulting firm, is partnering with a pharmaceutical company on a major transformation project. The pharmaceutical company operates a USFDA-approved plant in Bangalore and is looking to enhance its quality management systems. The goal is to drive improvements in product quality and regulatory compliance as part of this transformation. To achieve this, the client requires an expert with extensive experience in the pharmaceutical industry, specifically within USFDA-approved plants, with a focus on quality improvement and assurance.

An expert who can provide strategic guidance, evaluate current quality systems, and implement robust quality improvement measures. The expert will ensure that all quality processes at the USFDA-approved plant meet the highest standards of regulatory compliance and operational excellence.

Key Deliverables:

• Quality System Assessment:
• Conduct a comprehensive review of the current quality management system (QMS) in place at the plant.
• Identify gaps in compliance with USFDA regulations and areas for improvement in quality assurance processes.

• Development of Quality Improvement Strategies:
• Develop and implement strategies to enhance product quality, reduce defects, and improve overall operational efficiency.
• Align quality improvement efforts with regulatory requirements and industry best practices to ensure long-term sustainability.

• Quality Assurance and Control Implementation:
• Strengthen quality control mechanisms, including standard operating procedures (SOPs), documentation, and audit processes.
• Establish quality checkpoints throughout the manufacturing process to ensure adherence to the highest standards.