Soundarrajan Baskaran

Project (Jan-2022 to Aug-2024)

Client: Abbott

Scope/Activity: LDX Meter Integration with NPSW/OS upgrade and Validation

Project (JUl-2022 to Dec-2022)

Client: Abbott

Scope/Activity: NPSW validation/510k support.

Project (Jan 2023 to Dec 2023)

Client: Abbott

Scope/Activity: Manfacturing Process Equipment and software validation

Project (Jan 2024 to Dec 2024)

Client: Abbott

Scope/Activity: Lab Process Equipment and software validation.

• Conducted regular status meetings with internal teams and external partners to track progress against established milestones.
• Prepared/reviewed/Approved SLC deliverables SRC,URS/FRS,SDD,ADD,IQ,OQ,PQ,TM,SCS,FRA and executed Validation
• Prepared and performed Test Method Validation for LDX meter
• Performed NPSW validation and Equipment Qualification
• Ensured compliance with industry standards such as GAMP5 or 21 CFR Part 11 when performing validation activities.
• Analyzed data from various sources such as surveys, interviews, focus groups. to inform decision-making related to projects.
• Presented findings from data analysis in a clear, concise manner that was easily understood by stakeholders at all levels of the organization.
• Negotiated contracts with vendors and suppliers based on company objectives and budget constraints.
• Collaborated closely with senior management on long-term strategic planning initiatives related to projects in development or execution stages.
• Drafted reports summarizing progress made on projects for review by executive leadership team.
• Maintained records of all documents related to each project including specifications, change orders, invoices.
• Participated in cross-functional teams responsible for developing innovative solutions for complex problems.
• Ensured compliance with applicable laws, regulations, policies and procedures throughout the life cycle of each project.
• Coordinated resources across multiple departments and teams as needed for successful completion of projects.
• Advised other departments on best practices related to managing large-scale projects.
• Implemented effective communication protocols between internal teams working on different aspects of a given project.
• Facilitated resolution of conflicts between team members when necessary.
• Actively sought out feedback from stakeholders throughout the duration of a project in order to identify areas needing improvement or adjustment.
• Created and implemented processes to ensure successful completion of projects.
• Communicated effectively with stakeholders to ensure project goals are met on time and within budget.
• Provided guidance to team members regarding tasks assigned to them.
• Developed and maintained software validation protocols, plans and reports.
• Analyzed user requirements and developed system-level tests for validating user stories.
• Provided technical guidance in the development of test strategies, plans and scripts based on customer requirements.
• Developed traceability matrices to ensure that all requirements are tested.
• Documented results from each test cycle and reported any discrepancies found during testing activities.
• Participated in peer reviews of validation documents including protocols, summary reports.
• Collaborated with project teams to define product acceptance criteria prior to release.
• Managed the execution of User Acceptance Testing cycles for assigned projects.
• Performed system integration testing between various components of a larger system architecture.
• Assisted in developing training materials related to software features under test.

Project (Jul-2021 to Jan-2022)

Client: HCL Technologies/Abbott

Scope/Activity: LDX Meter remediation Evaluation

• Developed and maintained software validation protocols (VP, PSR) plans and reports.
• Created test cases( IQ,OQ,PQ,TMV,Dry run protocols) to validate the functionality of software applications.
• Performed manual and automated testing on software applications according to specifications.
• Identified, documented, tracked and resolved software defects.
• Conducted regression testing to ensure that existing functions have not been adversely affected by new code changes.
• Analyzed user requirements and developed system-level tests for validating user stories.
• Provided technical guidance in the development of test strategies, plans and scripts based on customer requirements.
• Developed traceability matrices to ensure that all requirements are tested.
• Documented results from each test cycle and reported any discrepancies found during testing activities.
• Ensured compliance with industry standards such as GAMP5 or 21 CFR Part 11 when performing validation activities.
• Documented entire validation process and recorded all changes.
• Developed protocols for validating products against internal and industry standards.

• Biologics Manufacturing Plant Equipment Qualification, software validation, and computer system validation as per 21 CFR 820 and 21 CFR part 11 regulatory standard.
• Inspected and tested Manfacturing and Lab instrumentation systems to ensure proper functioning.
• Developed and implemented inspection plans for newly installed instruments.
• Calibrated and repaired a range of process control instruments such as flow, temperature, pressure, level, analytical and other devices.
• Performed preventive maintenance on instrumentation equipment.
• Identified root causes of instrumentation system failures and recommended corrective actions.
• Provided technical guidance in the design of new instrumentation systems.
• Developed standard operating procedures for calibrating instruments.
• Troubleshot complex electrical and electronic circuits associated with instrumentation systems.
• Implemented safety protocols related to working with hazardous materials in the laboratory environment.
• Designed data acquisition systems for monitoring process parameters.
• Documented all work activities related to the installation, calibration, repair or replacement of instruments.
• Analyzed test results from various sensors and developed recommendations for improving system operations.
• Reviewed engineering drawings to ensure accuracy of specifications for instruments and their associated connections.
• Monitored operational trends within an industrial facility through use of SCADA software applications.
• Fabricated, wired, and integrated equipment.
• Developed standard operating procedures for instrumentation use, accounting for worker safety and related protocols.
• Performed troubleshooting using P&ID system diagrams and electrical schematics.
• Performed equipment and product maintenance and inspected systems to locate potential malfunctions.
• Calculated costs of equipment purchases and operations and assisted with department budget planning.
• Discussed engineering projects and products with both clients and other engineers.
• Reviewed customer feedback to brainstorm ways to improve processes and products.
• Created manuals and instructions regarding operation of electrical equipment and systems.
• Conducted internal audits to assess compliance with QMS requirements.
• Ensured adherence to ISO 9001 standards in all areas of the organization.
• Provided technical expertise on Quality Assurance best practices, methodologies, tools and techniques.

• Instrument Calibration/Maintenance, Software validation and Equipment Qualification
• Performed manual and automated testing on software applications according to specifications.
• Identified, documented, tracked and resolved software defects.
• Conducted regression testing to ensure that existing functions have not been adversely affected by new code changes.
• HAZOP Study and new Project Requirement evaluation
• Provided technical guidance in the development of test strategies, plans and scripts based on customer requirements.
• Developed traceability matrices to ensure that all requirements are tested.
• Participated in peer reviews of validation documents including protocols, summary reports.
• Ensured compliance with industry standards such as GAMP5 or 21 CFR Part 11 when performing validation activities.
• Monitored application performance after deployment into production environments.
• Investigated equipment failures, identified causes and initiated methods to resolve such issues.

• Biologics Manfacturing plant Equipment Qualification, Software validation
• Directed daily operations of instrumentation team, ensuring the completion of all tasks in a timely and efficient manner.
• Developed and maintained preventative maintenance schedules for all instrumentation systems.
• Coordinated with other departments to ensure optimal performance of instrumentation systems.
• Monitored and evaluated system performance, making necessary adjustments as needed.
• Ensured compliance with safety regulations related to instrumentation systems and equipment.
• Troubleshot complex problems related to instrumentation systems, using problem-solving techniques when necessary.

• API Equipment Qualification and software Validation
• Developed and implemented validation protocols for new processes, equipment, utilities and systems.
• Created detailed test plans to ensure compliance with applicable regulations and standards.
• Performed risk assessments of validation activities to determine appropriate levels of testing.
• Conducted design reviews of process, equipment and system changes to ensure compliance with regulatory requirements.
• Reviewed data from validation studies to ensure accuracy and completeness.
• Documented results of validation activities in accordance with FDA guidelines.
• Coordinated the execution of tests and generated reports on the performance of existing systems.
• Monitored progress against project schedules, budgets, resources allocations and timelines.
• Provided technical support for manufacturing operations related to process validation activities.
• Assisted in troubleshooting production issues by identifying potential root causes through investigations.
• Managed multiple projects simultaneously while adhering to deadlines and budget constraints.
• Identified areas where process improvements can be made in order to increase efficiency or reduce costs..
• Ensured that all documentation related to validations is properly maintained according to established procedures.
• Reviewed vendor-supplied documents such as user manuals, drawings, specifications, for accuracy prior to use.
• Provided guidance on regulatory requirements for various types of validations.
• Interacted with external vendors and contractors during the development and implementation stages of validations projects.
• Participated in internal audits and inspections related to validations programs or other quality assurance initiatives.
• Maintained current knowledge about industry trends and best practices related to product and process validations.
• Collaborated closely with cross-functional teams including Quality Control, Manufacturing, R&D, throughout the lifecycle of a project.
• Tracked software bugs and detailed information regarding findings and resolution techniques in documentation.
• Provided continuous process improvement and preventive and corrective actions to facilitate operational efficiency.
• Maintained and calibrated testing equipment to consistently produce reliable results.