Hello
I'm Rajiv Kumar
With a breadth of experience spanning pharmaceutical laboratory processes, analytical computer systems validation, software engineering, and project management. At present, I am utilizing my technical skills and knowledge to offer expertise at a prominent pharmaceutical company situated in Canada.
Computer System Validation
Support critical business processes, data management, and regulatory compliance
Empower Custom Fileds/Reports Validation
Verifies custom fields, data accuracy, and report compliance with regulatory requirements
Spreadsheet Validation
Ensures accurate, reliable, and compliant data through systematic testing and documentation
Database Design and Validation
Requirements gathering, logical and physical design, development, testing, deployment, and validation
Wordpress
Provide expert consultation related to website design, hosting services, or technical assistance
Nextcloud
Extensive expertise in installing and configuring Nextcloud securely for home or office setups, taking advantage of its powerful file syncing, collaboration, and security capabilities.
- Possess expertise in the validation of Waters Empower Chromatography Data System (CDS).
- Proficient in developing and validating Empower Custom Fields and Reports, as well as developing Microsoft Access database applications and customizing Excel spreadsheets.
- Skilled in the installation, configuration, and security setup of Linux server, Nginx proxy manager, Nextcloud, Docker, and Portainer.
- Proficient in managing Oracle, MS SQL, and MS Access databases, and programming languages such as Java, Visual Basic, and Python.
- Experienced in developing and securing WordPress websites.
- Administered the Empower Chromatography Data System (CDS) for over 10 years.
Assessed the manual reporting process and identified the necessary documentation requirements to ensure data integrity when transferring information into external systems. By implementing custom fields and reports in Waters Empower software and following best practices, I was able to develop and validate a more efficient and accurate process. This approach significantly reduced the time required for reporting and made it less prone to errors. Additionally, the new process is easily traceable and user-friendly, leading to improved operational efficiency.
As Technical Project Leader for a major pharmaceutical company, I was tasked with assessing uncontrolled MS Access database’s and developing a compliant and secure solution. The project involved multiple databases with repetitive tasks and lacked connectivity. After assessing the common features, I combined them according to relational database guidelines, designed and performed user acceptance testing, and performed a risk assessment and qualification for use in the lab.
To improve compliance in the quality control laboratory, I used the Split Database Architecture, which involved dividing the database into a front-end and a back-end. The front-end contained forms, queries, and reports, while the back-end contained tables. I distributed the front-end to each user, while the back-end was stored on a network share. This prevented users from modifying tables directly and reduced the risk of data corruption.
To prevent data breaches and unauthorized access, I created unique user accounts with passwords and configured user groups based on the level of access needed. This simplified management of access rights and administration. I also encrypted the database to prevent unauthorized access and automated the backup process to prevent data loss.
Finally, I developed usage and administration procedures to ensure that the new database was used in compliance with regulatory requirements.
During my work in the Quality Control lab, I evaluated approximately 150 spreadsheets, identified redundant calculations, and consolidated similar spreadsheets. Following the evaluation, 30 spreadsheets required further development and validation. To improve the process, I standardized the calculations, formatted input cells and formula cells separately for easier identification, and implemented locks for security. To ensure version control and prevent unauthorized access or editing, I also established storage security requirements.
In addition to these measures, I created a usage and management procedure, a user acceptance document, and a validation procedure aligned with the Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and/or Good Laboratory Practice (GLP) guidelines. By implementing these actions, the quality control lab’s spreadsheet accuracy and reliability were enhanced, enabling compliance with internal standards and regulatory requirements.
Let's Work Together
With the ongoing technological revolution changing our lives, society, and learning methods, my versatile technical expertise in pharmaceutical sciences, software design, and web development can help you accomplish complex projects efficiently.
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