M Rama Chandra Reddy

Highly organized and self-motivated professional experienced in project management, team development and process improvement. Skilled in developing and implementing strategies to increase efficiency and performance. Passionate about driving business growth and creating positive work environment.

• Successful facing USFDA Audit five times.
• Successful facing of TGA, Russian regulatory, Health Canada, WHO GMP, KFDA audits.
• Capacity enhancement of key products.
• High potent products validation and supplies for US, Europe, and Japan.
• Work teams formation and getting qualitative output.
• Zero safety incidents in 28 years of career.
• Contribution in preparation and implementation of safety standard rules.

• Overseeing all the plant operations and ensuring compliance with high quality operations.
• Driving operational excellence and maintaining regulatory compliance.
• Providing clear communications to all stakeholders.
• Evaluating cost reduction and simplification.
• Cross functional collaboration for achieving targets.
• Planning and execution of Oncology and non-oncology products.
• Handling of high potent products in Isolators.
• Installation and qualification of Isolators.
• Ensuring Isolators periodical qualification and preventive maintenance.
• Planning manufacturing of intermediates and API.
• Validating cleaning procedures for equipment.
• Handling of SAP transactions for production activities.
• Investigating product failures and providing CAPA.
• Coordinating with R&D & Technology transfer departments.
• Scaling up existing products and DMF filing of new products.
• Achieving production targets by supplying products on time.
• Continuous training and monitoring of manufacturing personnel.
• Contributing to preparation PHA and QRA.
• Handling of Purified water system.

• API Oncology
• API non Oncology