Tejashwini. S

Mobile no: +1-832-***-****

E-mail ID: ad4swz@r.postjobfree.com

Professional Summary:

Over 8+ years of experience in Pharmaceutical & Medical device Validation, leading CSV Projects, Equipment Validation, Cleaning Validation, and CQV in Manufacturing environments for Facilities, Utilities, and Lab equipment.

Experienced in the areas of design documentation (URS, FS, DS, and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).

Strong background in Commissioning, Qualification, Validations and Quality. Knowledge in FDA, GMPs, GAMP5, GxPs, Automation, CSV, MES, ERP, Lab equipment, PLC, and Kaye Validator.

Experienced in testing the equipment, processes, and systems used to develop and manufacture pharmaceutical/biological products.

Authored and executed validation documentation for aseptic processing systems, including protocols, test scripts, and summary reports, ensuring thorough testing and documentation.

Authored and executed FAT, SAT, Installation, and operational qualification (IOQ) and performance qualification (PQ) for automated equipment, systems, and Cold rooms.

Expertise in developing and documenting all the aspects of a Validation Master Plan (VMP), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), and Validation Summary Report (VSR).

Designed and executed Gauge R&R experiments for process improvement.

Proficient in all aspects of LIMS lifecycle management, including requirements gathering, system configuration, validation protocol development, execution, and documentation.

Proficient in identifying and mitigating risks throughout the SDLC process, while also continuously improving processes to enhance productivity, quality, and customer satisfaction.

Knowledge of Manufacturing IT systems such as Process Automation Systems (DeltaV), Manufacturing Execution Systems (Syncade), Data Historians (OSI PI), Enterprise Resource Planning (SAP), Laboratory Information Management Systems (Celabs), and Paperless Validation Systems.

Experienced in managing automation department compliance methodologies, strategies, and systems, including Data Integrity and SOP periodic review.

Familiar with Manual Testing, HPQC, HP ALM, Docspace, SAP ERP, Defect Tracking, Defect Management, and Track Wise tools.

Conducted thorough testing and validation of PLC programs to verify functionality and performance, collaborating with engineering teams to address any issues or discrepancies identified during testing.

Expertise in conducting TMV analyses to validate equipment, systems, and processes, ensuring compliance with regulatory standards such as FDA and EMA.

Provided training and technical support to operators and maintenance personnel on SCADA system operation, troubleshooting techniques, and best practices for system maintenance and reliability.

Lead validation assignments involving Test Method Validation (TMV), Process Characterization, and Design of Experiments (DOE), applying diverse engineering principles and knowledge to ensure thorough process and equipment validation.

Proficient in working with electronic validation systems such as KNEAT or similar platforms, showcasing adaptability to modern validation technologies.

Skilled in instrument integration with CDS platforms, including chromatography systems such as HPLC, GC, and mass spectrometry detectors.

Worked alongside Lead Engineer, performing 1st and 2nd Smoke Study work for Vial Filler equipment; executing visual data recording, and processing collected data into reports.

Strong documentation skills for writing and executing verifications per FDA regulatory requirements and under a Quality System design control process and procedure.

Skilled in diagnosing and resolving issues within Rockwell automation solutions, leveraging in-depth knowledge of hardware, software, and networking components to optimize system performance and maximize operational efficiency.

Hands-on experience using Kaye Validator, AVS system, Val-Probs, and Ellab Dataloggers.

Maintained a clear and auditable Traceability Matrix, demonstrating thorough documentation and adherence to established CSV procedures.

Leveraged FMEA outputs to develop comprehensive risk management plans, defining mitigation strategies, responsible parties, and timelines for identified failure modes, enhancing overall CSV effectiveness.

Skilled in identifying and addressing any operational issues that arise in automated packaging lines, ensuring they function at their best and minimizing any periods of downtime.

Managed the LIMS Support Team; assigned resources, tracked progress, and reported status.

Experienced in validating SaaS platforms for regulated industries. Ensures FDA and GxP compliance, and excels in protocol development and cross-functional collaboration.

Proficient in authoring and reviewing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for diverse manufacturing equipment including bioreactors, TFFs, Autoclaves, Liquid Filling machines, Lyophilizers, tube welders.

Managed pharmaceutical-grade utilities including steam plant, HQS, electrical systems, WFI, and compressed gases.

HVAC and Environmental Conditions Verification.

Skilled in interpreting chromatographic and spectral data generated from HPLC, GC, and UV-Vis analyses for qualitative and quantitative assessments.

Led CSV programs for clinical systems, including the authoring, reviewing, and approving of validation deliverables such as Change Controls, Plans, Specifications (e.g., URS), Traceability Matrices, Test Scripts, and Reports.

Strong knowledge of pharmaceutical/medical device regulations/guidelines including 21 CFR Part 11, Part 210, Part 211, Part 820, ISO 13485 & 14971.

Skills:

CSV, Data Integrity, LIMS, Veeva, MES, SAP, Minitab, ELN, CDS, Equipment Validation, Process Validation, Commissioning, Qualification, Validation, User Requirement Specifications (URS), Functional Requirements Specifications (FRS), User Account Reviews, Facilities, Utilities, Equipment, Factory Acceptance Test (FAT), Site Acceptance Test (SAT), GAMP, GxP, cGMP, cGCP, cGLP and GDP, Requirement Specifications, Master Validation Plan, Risk Assessments, IQ/OQ/PQ, Test Scripts, Change Controls, Traceability, Matrices, Data Acquisition and Processing, Validation/Qualification Summary Reports, Smoke Testing, Quality Assurance, Continuous Improvement Practices, Data Migration and Compatibility Testing, Regulatory Audit Preparation and Representation, Records Retention Management, Cross-Functional Collaboration.

Professional Experience:

Point Biopharma, IN Jun 2019 to Present

Senior Computer System Validation Engineer

Led developing and executing protocols and test scripts, identified gaps, wrote GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.

Developed and executed validation plans, protocols, and test cases to ensure computer systems met the validation procedures.

Experienced in compliance with regulatory standards such as FDA 21 CFR Part 11 and data integrity guidelines when using CDS systems.

Trained colleagues in Gauge R&R methodologies and Minitab software.

Reviewed and approved final Execution reports, likely incorporating time study data to evaluate production efficiency.

Led the validation efforts for computer systems affected by mergers, ensuring seamless compliance with regulatory standards and data integrity.

Collaborated with cross-functional teams during acquisition, providing expertise in computer system validation and quality management.

Reviewed and approved Functional Specifications and Technical Specifications for the interfaces developed between CDS Systems, LIMS, and SAP.

Created and executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) scripts for all GxP systems in HP ALM.

Conducted gap assessments and remediation activities to ensure alignment with ICH guidelines, identifying areas of non-compliance and implementing corrective actions to mitigate risks.

Successfully aligned CSV protocols, documentation, and validation processes with the consolidated quality management systems post-merger.

Contributed to the development and execution of validation plans for newly acquired assets, including Configuration Specifications (CS) and User Requirement Specifications (URS).

Authored and executed validation documentation for QMS software, process equipment, automated equipment, and systems according to GAMP 5 Validation Life Cycle

Managed the maintenance of PI Historian and other infrastructure components to ensure secure and accessible real-time system data.

Served as a Computer System Validation Subject Matter Expert and provided strategic and consistent guidance for GxP computerized systems including LIMS, Veeva, MES, SAP, ELN, etc.

I have conducted regular reviews of the MES to assess its ongoing compliance with regulatory requirements and organizational needs, initiating revalidation activities as necessary to ensure continued compliance.

Led the design, development, implementation, and execution of test scripts/ plans to identify software problems and their causes.

Led CSV programs, including writing, reviewing, and approving CSV deliverables such as Change Controls, Plans, Specifications (e.g., URS), Traceability Matrices, Test Scripts, and Reports.

Owned CSV-related Deviations and CAPAs. Managed remediation efforts related to CSV and Data Integrity.

Led GxP computer system audits and ensured computer system vendors were qualified before system implementation.

Developed lifecycle documents for new assets including Configuration Specifications (CS) and User Requirement Specifications (URS).

Performed and reviewed computerized system validation deliverables for lab equipment and manufacturing equipment according to 21CFR Part 11, Annex 11, GAMP 5, and other regulatory requirements.

Approved, and executed validation deliverables for computerized systems and IT infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity, and GAMP5.

Guided the project team in completing the required validation deliverables/ activities in each phase of SDLC.

Worked cross-functionally with Validation, Quality, and System Owner groups to manage IQ/OQ/PQ execution by project timelines.

Generated reports and documentation for Gauge R&R studies using Minitab.

Proficient in developing and executing validation strategies for equipment qualification, process validation, and validation by GMP guidelines.

I have hands-on experience with the GAMP V-Model, particularly in its application to validate automated systems within regulated industries like pharmaceuticals.

Completed all validation package documents (e.g., IQ/OQ/PQ, Summary Report, Traceability Matrices) including stakeholder review and approval management.

Coordinated day-to-day operations of the IT department's GxP computerized system Validation activities.

Designed and executed validation including support of computer system validation protocols to ensure consistency of data production.

Provided startup and commissioning services for automation control systems/HVAC systems for pharmaceutical manufacturing processes.

Authored and executed IQ/CQ/OQ protocols for PLC-based SCADA systems associated with automated Data Acquisition systems and utility systems using Commissioning & Qualification (C&Q) Approach.

Strong understanding of risk management principles and the ability to identify, assess, and mitigate potential risks associated with SaaS systems within regulated environments.

Authored, Reviewed, and executed User/Functional Requirements Specifications (URS FRS), Risk Assessments (RA), Design Qualification (DQ), and Qualification Test Protocols (IQ/OQ/PQ).

Performed all aspects of Quality Systems Management (QSM) processes (Change Control, Deviation, Corrective and Preventable Actions) as well as Validation Maintenance of computerized systems.

Developed validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, and discrepancies.

Developed and maintained validation templates and workflows within the KNEAT platform to ensure alignment with regulatory requirements and company standards.

Planned, Wrote, reviewed, and Executed CSV protocols, deviations, corrective actions, Summary Reports, Trace Matrices, and documentation of results.

Responsible for authoring GxP system lifecycle documentation, such as Validation Plans which consist of Validation Scope and Strategy, Requirements Verification, Evaluation Traceability Analysis, Software Design Evaluation & Verification, Unit Testing Strategy and Functional Testing Strategy, Test Protocol Development, Test Execution, General Acceptance Criteria.

Led the validation efforts for Clinical Systems including CTMS, CDMS, EDC, and Safety Systems, ensuring compliance with 21 CFR Part 11, GAMP 5, and other regulatory standards.

VSR Implemented qualification & validation activities within projects of new and existing computer systems.

Created verification and validation test designs, and test scripts and performed test execution (CAPA).

Collaborate with operations and automation colleagues to manage and perform user account reviews, ensuring adherence to compliance standards.

Developed and executed Decommissioning Plans and Reports, ensuring seamless transitions and compliance during system decommissioning processes.

Coordinated validation efforts between tablet compression machines and packaging equipment to guarantee product integrity from manufacturing to distribution.

Hands-on experience in executing equipment validation protocols and generating related documentation.

Developed and executed validation documentation including protocols, test scripts, and summary reports for HPLC systems, ensuring thorough testing and documentation of system performance.

Adept at identifying and resolving challenges during the Commercial Filling Line Equipment and Isolators qualification, ensuring seamless project progress.

Developed and Executed Decommissioning and Moving forms for various equipment such as FIL, HPLC, UPLC, Freezers and Refrigerators.

I have integrated the ICH Q9 model into CSV processes, focusing on risk assessment and mitigation throughout the system lifecycle.

Managed cost, tasks, schedules, and resources associated with the overall initiatives related to the LIMS Project.

Executed validation protocols meticulously, documenting results, deviations, and resolutions rigorously to maintain compliance and traceability throughout the validation process.

Experienced in commissioning, qualifying, and validating sterile SVP filling lines and associated equipment, including WFI systems, autoclaves, and automated filling lines.

Developed with other Commissioning Test Plans for Compressed Air, Purified water, and HVAC verification.

Responsible for validation and implementation of PLC, HMI, and SCADA software for control systems and equipment.

Reviewed and approved test methods and sampling plans for aseptic processing equipment validation, ensuring compliance with regulatory requirements and industry standards.

Proficient in operating and maintaining High-Performance Liquid Chromatography (HPLC) systems for analytical testing and quality control purposes.

Experienced in utilizing UV-visible (UV-Vis) spectrophotometers for quantitative analysis and spectral characterization of various compounds.

Active involvement in Audits, Periodic Reviews, and Change Management Support.

Update Data Integrity Assessments and route them through change control, ensuring accuracy and compliance with regulatory guidelines.

Gilead Sciences, CA Nov 2016 to May 2019

Sr. Computer System Validation Engineer

Developed CFR Part 11-compliant computer and automation systems Validation Plans, Qualifications Protocols (IQ/OQ/PQ), User Requirements, Traceability Matrices, Reports, and all documents, and deliverables within the scope of the validation plan.

Supported computer systems Risk Assessment and gap assessment remediation activities.

Designed, reviewed, and executed validation documents activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment /utilities/facilities and generate reports that summarize results, specification, and its acceptance criteria.

Developed and Executed Validation life cycle deliverables which include validation plans, requirement specifications, Risk Assessments, test plans, (IQ, OQ, PQ) protocols, Traceability Matrix, and validation reports for Lab equipment in compliance with GxP and FDA guidelines.

Led the validation studies and execution of protocols for systems impacted by mergers, adhering to GxP and FDA guidelines.

Validation experience in the implementation of TrackWise Quality Suite and SAP

Developed Master Test Plan and Summary Reports for LIMS Implementation.

I have developed numerous validation plans for MES implementations, outlining comprehensive testing approaches, protocols, and acceptance criteria tailored to each project's unique requirements.

Knowledgeable in performing method validation and verification studies for HPLC and GC assays, ensuring compliance with regulatory requirements such as FDA and ICH guidelines.

Collaborated with project management to assess the validation status of acquired systems and develop remediation plans as needed.

Authored and executed validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, for GC and GC Headspace Sampler systems to meet GxP and FDA guidelines.

Conducted audits for existing validation activities and participated in pre-approval inspections to identify and address deficiencies in quality systems resulting from acquisitions.

Involved in preparing compliance reports about the existing status of the cGMP, GCP, and GLP.

Authored Installation Qualification, Operational Qualification, and Operational Qualification protocols for Lab Instruments.

Conducted risk assessments of OSI PI systems to identify potential vulnerabilities and implemented mitigation strategies to ensure data integrity and system reliability.

Led efforts around Data Integrity Compliance Part 11- for electronic signatures and electronic records.

Proactively engaged in risk assessment activities to identify potential gaps or deficiencies in validation processes and documentation, implementing corrective actions as needed.

Executed validation studies, writing protocols, documenting results, and generating final reports, and summaries of work for release of equipment tested.

Prepared, reviewed, and executed process validation protocols, reports, and other relevant documents.

Reviewed Risk Assessment Documentation to check the areas with deficiencies, reviewed Corrective and Preventive Action (CAPA), and SAT testing, and drafted Remediation Plans for the project management approval after the GAP Analysis.

Authored and executed qualification protocols for laboratory equipment including Chromatography, Autoclave, Spectrometer, and Microscopes.

Ensured compliance with regulatory standards (e.g., FDA, GMP, GAMP) by utilizing KNEAT software to maintain complete and accurate validation documentation.

Responsible for authoring and executing Test scripts and tracking Defects using HP ALM.

Responsible for planning, designing, and executing complex testing solutions including Functional, Regression, and End-to-end testing.

Developed validation plans and protocols for Centrifuges, ensuring proper validation of rotor speeds, temperature control, and overall performance for various sample types and volumes.

Responsible for performing Root-Cause Analysis, Data Impact Analysis, and Gap Analysis for the defects encountered during the major release of any GxP-applicable Change Management System.

Participated in product definition, system architecture, requirements writing, requirements management, requirements analysis, risk analysis, hazard analysis, product test and evaluation, System Verification & Validation, and design control documentation.

Developed, executed, and reviewed qualification protocols, SOPs, validation plans, summary reports, change controls, traceability requirements, user requirements, functional and configuration specifications, gap, risk, and Impact assessments.

Involved in Factory Acceptance testing (FAT), and Site Acceptance Testing (SAT) of Lab equipment-related related systems as required by the company.

Drafted, prepared, and documented software validation protocols (IQ, OQ, and PQ) for integration of LIMS.

Implemented Root Cause Analysis (RCA) on deviations and successfully resolved and documented the deviations with actions taken following FDA regulations using Good Documentation Practices.

Performed audits for existing validation activities and conducted pre-approval inspections to identify deficiencies in quality systems.

Coordinated validation activities between lyophilizers and vial filling lines, ensuring freeze-drying processes aligned with downstream packaging requirements for product stability and shelf-life preservation.

Generated Validation Summary Report to summarize and document all validation activities.

Review system support documentation to ensure compliance with regulatory standards, identifying and addressing any gaps or deficiencies.

Developed, reviewed, and approved Requirement Traceability Matrix (RTM) and Validation Summary Reports, ensuring comprehensive coverage of validation activities.

Experienced in developing and reviewing Decommissioning Plans and Reports, ensuring compliance during system transitions.

Monitor and trend issues to identify and develop preventative solutions, proactively addressing compliance concerns and ensuring continuous improvement.

Abbott Molecular, Desplaines, IL Jun 2015 to Oct 2016

Validation Engineer

Developed and executed validation plans, user requirement specifications, protocols, and reports for IQ/OQ/PQ/relevant test scripts, qualification reports, and summary reports for Equipment upgrades.

Involved in preparing the Validation plan and Validation Summary Report to summarize all the Validation activities.

Collaborated with cross-functional teams to update validation protocols and change controls in response to acquisitions.

Participated in technology transfer activities associated with acquisitions, ensuring the smooth validation of new equipment.

Drafted and executed Qualification and Re-Qualification protocols for analytical Equipment such as HPLC, GC, UV-visible spectrometer, TOC Analyzer, and ICPMS.

Proficient in integrating validation processes within established quality management systems, ensuring alignment with company policies and procedures to uphold product quality and regulatory compliance.

Ensured protocols, verifications, validation plans, and summary reports generated during validation/ qualification activities were stored according to the procedure.

Proficient in Clinical systems including CTMS, CDMS, EDC, Veeva Vault, QMS, and Safety Systems.

Conducted validation testing and data analysis to verify the performance and reliability of medical devices, ensuring adherence to design specifications and quality standards.

Coordinated with cross-functional teams to update validation protocols and change controls in response to acquisitions or changes in regulatory requirements.

Drafted SOPs, batch records, and line templates.

Involved in Design and Failure mode analysis (DFMEA) of the products as mentioned and Class 2 medical devices.

Drafted protocols and executed tests for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment like PLCs, Injection Molding machines, Dryers, etc.

Led the validation efforts for critical systems and processes, ensuring compliance with regulatory standards and facilitating successful audits and inspections.

Participated in developing and updating Equipment and Software validation protocols and change controls.

Identified Equipment and Equipment validation quality critical parameters and updated the specifications.

Wrote, updated, and revised the production batch and Equipment validation reports.

Coordinated and supported the execution of Equipment validation activities.

Reviewed and approved the test methods and sampling plans for Equipment validation.

Participated in technology transfer activities.

Supported in writing master validation plan for Equipment validation activities.

Involved in writing deviations and performing Effectiveness checks.

Education:

Bachelor’s in pharmacy in 2013 from Osmania University.

Contact this candidate