RAJESH CHAUDA

• Worked on Lonza's COGS Project involving, validation of Emerson DeltaV DCS, Sartorius Single Use Bioreactors, Raman Spectrometers, Alternating Tangential Flow (ATF) Filters, BioWelders, Centrifuge, etc.

• As a Validation Consultant for Equipment Commissioning and Qualification focusing on Computerised System Validation (CSV) in order to set-up a brand new GMP manufacturing facility for Oncology Sterile Injectable/ Syringe production.

• Worked as a Validation Consultant for Equipment Qualification and Computerised System Validation (CSV) within Validation Department in order to set-up a brand new GMP manufacturing facility (Viral Vector Suite) for AZ COVID-19 vaccine production.

• Worked as a Laboratory Equipment Qualification and Computerised System Validation (CSV) specialist within Quality Control, Chemistry Department and set-up a new GMP lab for the client
• Led a remediation project for CSV and equipment life-cycle management.

• As an Analytical Expert (SME), led a FDA Inspection Remediation Project for quality operations (Analytical/ Chemistry Laboratory) within sterile injectable manufacturing plant, involving re-test of all commercial and stability batches/ products, laboratory operation assessment, developing a strategic action plan to address the gaps in the process/ resource, Equipment, Methods and Training and lab refurbishment
• Provided guidance on other remediation activities, i.e., data integrity, equipment qualification and life cycle management, internal audits and investigations (RCAs, Deviations, CAPAs, etc.).

Worked as a Direct Procurement SME (M-ERP Deployment), Senior Scientist (Analytical and Formulation Development Expert), Compliance Specialist/Independent Reviewer and Development Scientist.

Moved to different sites with increasing responsibilities to lead M-ERP deployment (as a Direct Procurement SME), ICH Q3D guidelines implementation, LabWare LIMS (CLS- Core Laboratory System) and QMS deployment, continuous improvement initiatives, technology transfers, method development/ optimisation and validation, analytical strategy initiatives, remediation of regulatory findings (involving re-test of all commercial and stability batches/ products and implementation of Data Integrity- ALCOA+ principles), waste water treatment and downstream processing projects and re-process/ re-work of high impurity batches of API and worked within Consumer Healthcare R&D and Biopharmaceutical Technical/Global Manufacturing & Supply categories, dealing with cross- functional stakeholders at different levels- nationally and internationally.

• With MS&T, led a project to develop a method to optimize the run-time to make efficient in-process checks of different components in Active Pharmaceutical Ingredient (API)
• The run-time reduced by 65% from 55 minutes to 20 minutes, which had significant impact on reduced production time and cost by ~30%.

• As one of the cost reduction initiatives and innovative area for packaging materials for one of the oncology products that is supplied worldwide, I got involved as an analytical lead to manage project timings and resource for 2 analysts in a new plugs' compatibility project with expected saving of £100K per annum
• Led process improvement project to improve the manufacturing overall equipment efficiency (OEE) by having effective, time saving and validated cleaning processes for sterile manufacturing equipment and manufacturing lines
• Led different small but challenging projects in support of world-wide customer complaints, manufacturing process deviations and investigations, raw material quality problems.

• Within Faculty of Pharmaceutical Sciences, worked on a cancer research project for ex-vivo/in-vitro screening of di-block copolymer formulations to look into the activity profile in mammalian cell models, in order, to develop novel drug delivery systems for the treatment of breast, lung, and colorectal cancers
• As a result, the initial screening of the formulations shown promising results on the models by having cytotoxic effects on cancer cells, leading to further work on developing the formulations for in-vivo experiments.