Dr. Prashanth Kumar Alay, Ph.D. Email & Phone Number

Columbia, Mo, Us

United States

Columbia, Missouri, United States

Malta

Malta

• Manage and interpret quality system requirements and evaluate the effectiveness of the organization in meeting those expectations, and develop a team approach for addressing any deficiencies;• Develop, implement and guide the CAH Malta Manufacturing site through external audits, including corporate audits, MDSAP/ISO13485:2016, FDA;• Consistently identify, evaluate and execute opportunities for continuous improvement;• Maintain company documentation of procedures and ensure compliance with established certified standards, applicable regulations, and company policies;• Assure compliance with regulations as MDSAP and ISO13485 and others at the CAH Malta site. Execute quality plans for MDSAP/ISO13485:2016 implementation;• Provide guidance and support for determining regulatory/compliance strategies to meet the requirements of current regulations and customer requirements;• Maintain company documentation of procedures and ensure compliance with the Cardinal Health QA/RA integration plan;• Support the various departments on compliance issues and CAPA investigations. Manage corrective actions to assure effective corrective and preventative actions to avoid repeat issues;• Act as senior investigator for critical quality issues as requested by Quality Management;• Conduct internal audits and support site during internal and external audits. Actively participate in and support company and plant wide initiatives including six-sigma, lean, safety and cost reduction;• Utilize benchmarking of best in class processes to provide information for continuous improvement;• Ensure conformance of supplied goods and services to specified requirements;• Ongoing maintenance of the CAH Malta SUPPLIER QUALITY approval system which ensures that supplied goods and services conform to specific requirements via established procedures which describe supplier selection, control and evaluation, documents review, purchasing process and supplier purchasing agreements;

Rome Area, Italy

Project: Investigation of new human DNA topoisomerase IB inhibitors. • Production and purification of the enzyme human topoisomerase IB and mutants. • Testing of natural compounds and metallo complexes as topoisomerase inhibitors by enzymatic assays. • Computational simulation of the compound and enzyme interaction. • Understand the mechanism of action of the different compounds in relation to the catalytic mechanism of the enzyme human topoisomerase IB.

Hyderabad Area, India

Oversees and directs production operations for a manufacturing organization. They lead production operations, coordinate production staff and equipment, and ensure the quality and profitability of products.Work with production teams to ensure cost-effective, high quality and timely delivery of products.Recommend changes in workflow, operations and equipment to maximize production efficiency.Provide job training to workers to meet production goals.Investigate problems, analyze root causes and define resolutions.Ensure that final product meets quality standards and customer specifications.

Hyderabad Area, India

Fully implement the production program according to the instructions of the Production Manager.Monitor and ensure compliance with the Safety Standards as well as Good Manufacturing Practice (GMP) requirements to ensure product quality.Handling, Setting and Changing Set of Machine Machines.Schedule, coordinate, supervise, and generally manage the staff working on the Production line.Ensure productivity, quality, hygiene and proper behavior of staff.Identify and report timely to the Technical Department of any mechanical damage and coordinate for timely correction.Timely and correct input of required data into production forms and calendars.Collaborate with the Packaging team for efficient and quality packaging of products

Hyderabad Area, India

Perform technology transfers of pharmaceutical drug product processes among R&D and Production sites. Manage and mentor the team of experts performing technology transfers.Assess processes for gaps, design experiments, write pilot/ batch protocols and batch records, supervise manufacturing batches, assess experimental data, draw scientifically sound conclusions, and write technology transfer reports.Perform manufacturing process reviews of processes intended for technology transfer with an eye towards manufacturability, robustness, and validation success.Assist in the completion and review of sections of documents needed to complete such transfers.Provide scientific trouble shooting having always in mind the quality of products.Managing projects to meet Company timelines.

Doctor Of Philosophy (Phd), Biochemistry And Molecular Biology, Phd-Presidential Decree 28/12/2000,Biochemistry And Molecular Biology,A

Master Of Pharmacy - Industrial Pharmaceutics Sciences, Pharmaceutical Sciences, Distinction

Activities and Societies: Modules: Pharmaceutical technology, Advanced Physical Pharmaceutics, Biopharmaceutics & Pharmacokinetics, Novel.

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, Pharmaceutical Sciences, And Administration, Distinction