Tejasree Kovuri
Summary
Validation Engineer with over 7 years of experience in developing, reviewing and approving validation deliverables for SOP compliance & regulatory requirement. Experienced with workflow design and optimization, delivering qualification events, as well as change control support. Manage vendor interactions, tracking and investigations and interact with stakeholders to ensure Lean Validation Approach SOP alignment.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Sr Validation Engineer
Boehringer Ingelheim
02.2023 - Current
- Generating, reviewing, and approving Validation deliverables (Validation Plan, Protocols, Reports, Impact assessment, Risk assessment, URS, IQ, OQ, PQ, Traceability Matrix, Periodic Reviews, etc.) for validation/qualification activities
- Conducted visual inspections as part of validation and qualification processes to confirm equipment readiness and compliance
- Managed audit preparations, supported internal and external audits, and addressed validation-related findings
- Preparing an inventory for periodic reviews using Trackwise QMS module and conducting periodic reviews for Equipment and Computer Systems
- Ensuring appropriate validation activities are occurring to comply with validation planning and applicable SOPs before System operation
- Ensuring all system-specific SOPs and SLC documents are in place before the operation phase
- Designing and optimizing work processes and managing all qualification activities of Lab equipment and Computerized systems in accordance with GMP
- Supporting change control activities, deviation resolution (CAPA), and effectiveness checks for validated systems
Validation Engineer
Sun Pharmaceuticals Industries Ltd.
06.2016 - 01.2022
- Created and executed commissioning and qualification protocols/test plans for facilities, utilities, and equipment using a risk-based approach
- Conducted visual inspections to ensure equipment adherence to design specifications and operational readiness
- Prepared site validation documentation such as qualification protocols, validation master plans, risk assessments, and periodic reviews
- Implemented and coordinated commissioning and qualification of manufacturing equipment and computer systems for use in regulated and non-regulated operations
- Conducted Risk Assessments, Impact assessments, and established system boundaries collaboratively
- Identified deviations encountered during IQ/OQ/PQ execution and worked with supervisor to implement mitigation solutions
- Compiled and analyzed validation data, wrote protocols, reports, and made recommendations for changes and improvements
- Facilitated and supported validation training, change management, and periodic review of validated systems
- Generated, reviewed, and edited Standard Operating Procedures
- Reviewed and verified ETOP’s
- Generated and executed protocols for DQ, FAT, SAT, IV OV, IQ, OQ, and PQ
- Supported equipment troubleshooting and close out of discrepancies and deviations
- Responsible for site requalification plan execution and implementation
- Streamlined testing requirements while maintaining regulatory and corporate compliance
- Drafted Standard Operating Procedures (SOP) for new operational equipment
Education
Masters - Biomedical engineering
University of Bridgeport
Bridgeport, ConnecticutBachelors - Biomedical Engineering
Saveetha School of Engineering College
Chennai, Tamil NaduSkills
- Training and mentoring
- Statistical analysis techniques
- CAPA investigations
- Equipment qualification
Certification
Good clinical practices
Timeline
Sr Validation Engineer
Boehringer Ingelheim
02.2023 - Current
Validation Engineer
Sun Pharmaceuticals Industries Ltd.
06.2016 - 01.2022
Masters - Biomedical engineering
University of Bridgeport
Bachelors - Biomedical Engineering
Saveetha School of Engineering College
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