Praneeth Kakarla

[email protected]
(305) 432-5454
Accomplishments:
 Software Quality Assurance professional with over 5+ years of experience in Medical/health/ Pharma agency (FDA,
MHRA etc.) regulated industries with a proven track record managing teams as well as personal experience in the
areas of: Computer System Validation, Infrastructure Qualification (including GMP environment), Change Control,
Metrics, QMS (Deviations/CAPA, Quality Investigations, Training, Supplier Management) and Auditing. Exposure to
systems in R&D, Records Management, Sales/Marketing, Information Technology, Training, Quality Assurance.
 Experience in pharmaceutical sciences, professional with broad based GxP experience in Computer System
Validation (CSV), pharmaceutical process validation, equipment qualification, sterilization, manufacturing
equipments, supporting both proprietary and generic pharmaceutical industries.
 Knowledge of GAMP, GxP's (GCP, GLP and GMP), 21-CFR Part 11 regulation of Electronic Records, Electronic
Signatures and Audit Trails.
 Good experience in performing manual testing methods like Integration Testing, Black box Testing, Functional
Testing, Regression Testing, Front end Testing and automated testing tools like HP Quality Center.
 Experience in FDA 21 CFR Part 210, 211, 820 and ISO 13485 for medical and pharmaceutical industries.
 Experience in Software Development Life Cycle (SDLC), familiar with Waterfall, V-shape model and agile model.
 Highly experienced with Computer System Validation, Process Validation, Qualification of Equipment, Building
Management System (BMS, BAS), and Process Automated Equipment.
 Experience in reviewing and developing User Requirement Specifications (URS) and Functional Requirement
Specifications (FRS) in compliance and conformance with FDA rules and regulations.
 Comprehensive knowledge and extensive experience in technical writing of Validation protocols (Installation
Qualification - IQ, Operational Qualification - OQ and Performance Qualification -PQ), Validation Master Plan
(VMP), SOP's, Test Summary Report, Test Plans, Test scripts, and Requirement Traceability Matrix (RTM) in FDA
regulated environments.
 Good working knowledge of other Regulatory Operations software Argus Safety, Argus Interchange, EDMS and
Qumas/SharePoint.
 Good experience in writing Risk Assessment, Remediation Plan, Deviation report, and User Acceptance Testing
(UAT).
 Proficient in dealing with Change Control Management System (CCMS), Laboratory Information Management
System (LIMS), Enterprise Document Management System (EDMS).
 Good understanding of Lean six sigma methodology, Root cause analysis (RCA), Corrective and preventive action
(CAPA) and Failure Mode Effect Analysis (FMEA).
 Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the remediation
plans to mitigate the non-compliance.
 Involved in Data Center Migration Project and responsible for developing the validation deliverables of DataCenter
Migration.
 Experience in writing and developing Test Plans, Test Scripts, Test Procedures, and Test Summary Reports of all the
laboratory equipment's.
 Involved in writing the User Acceptance Test Summary Report.
 Used tools like Test Director for submitting testing reports for bug-reporting and bug-tracking.
 Expertise in automated testing tools such as Mercury Quality Center, HP Quality Center and experience in Quick Test
Pro (QTP), and Load Runner.
 Supported the conversion of a cosmetic manufacturing facility to a GMP OTC FDA regulated facility.
Alcon - Houston, TX June 2017 - Present
Validation Engineer
Alcon has one mission to provide innovative products that enhance quality of life by helping people see better Alcon's
leadership is grounded in cutting-edge innovation and breakthrough technology, transforming the way treat eye diseases
and conditions. Alcon is helping people see the world better through advanced surgical, pharmaceutical and vision care
products. As a (CSV) Engineer, I was involved in the gathering and involving the validating new Labeling Application
systems.
Responsibilities:
 Followed Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for
systems as per GxP (GLP, GCP, and GMP) FDA Assessment.
 Profound knowledge in pharmaceutical/medical device regulations like FDA 21 CFR part 820 and ISO 13485.
 Equipment validation and Technical documentation as per FDA/ISO 13485 and GAMP regulations.
 Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis (RCA),
evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness.
 Analyzed test scripts to be compliant with 21CFR Part regulations, maintaining validation Electronic records and
following relevant SOPs.
 Well versed in industry guidelines (FDA, MHRA, EU, USP, etc) and provide annual Data Integrity training.
 Work collaboratively across functions with Quality Management, IT, Business, Vendors and Consultants to plan,
coordinate and execute computer system validation activities 
 Developed Validation Master Plan (VMP) in accordance with FDA compliance standards
 Developed IQ/OQ/PQ and MSA protocols by identifying inspection and test activities, special measuring and test
equipment, appropriate statistical techniques, data collection methods, and sampling plans for establishing, controlling
and verifying process stability/capability.
 Provide support and insight into qualification and validation activities and work effectively with engineering and
operations teams in completing these tasks.
 Expertise in Problem solving and tracking bug reports using Bug tracking tools such as Quality Center, Bugzilla,
Microsoft TFS.
 Qualification and validation of Packaging Lines including Serialization Systems.
 Involved in preparing compliance report about existing status of the cGMP, GCP and GLP.
 Successfully closed CSV related CAPAs in both Automation and R&D.
 Involved in reviewing Validation deliverables Validation Master Plan (VMP), Validation Summary Documents
(VSD), Validation Summary Reports (VSR), Installation Qualification/ Operational Qualification/ Performance
Qualification, and Requirements Traceability Matrix.
 Extensive experience in developing Test Plan, Test Cases and Test Summary Report.
 Reviewed validation (IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensure validation reports were
qualified to company and regulatory requirement.
 Validated computerized laboratory equipment based on GAMP 4 & 5.
 Involved in auditing the application for 21 CFR part 820, IEC 60601-1, ISO 13485, and ISO 14971. Compliance
related to Electronic Signatures and Electronic Records for Trackwise System.
 Experience in Data Migration, Periodic Review, Change Controls, and Change Reporting, GAP Analysis, and Risk
analysis, CAPA, FMEA and Remediation Process.
 Performed Statistical analysis for the FMEA risk assessment and performed Fault Tree analysis.
 Prepared detailed SOPs for IQ and PQ for validating Autoclaves and HPLC detailing more on Filter sterilization,
saturated steam checks including vendor specifications.
 Authored Requirement Traceability Matrix (RTM).
 deliverables for projects –Issues Log, Incident Reports, IQ Protocol/Report, OQ Protocol/Report and Trace
Matrix
Genzyme Corporation, Framingham, MA Jan 2016- May 2017
Validation Analyst
Genzyme Corporation is one of the world’s leading biotechnology companies with substantial development programs in
cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical needs. Genzyme’s products are
focused on rare inherited disorders, kidney disease, orthopedics, cancer, transplant and immune disease. As a Validation
Engineer I was responsible for implementation of validation activities associated with qualification of new and existing
equipment, instruments and facilities used in manufacture, testing, and storage of medical products.
Responsibilities:
 Documented various validation deliverable of system life cycle as required by FDA regulations under 21CFR.
 Reviewing the User Requirement Specification (URS) and the Functional Requirement Specification (FRS) document
and analyzing the causes leading to discrepancies and failure of the pre-executed OQ scripts.
 Involved in creating test bed to check the Installation and Operational Qualification (IQ/OQ) for the application.
 Performed the ERES assessment of the overall functionalities of Argus Safety and evaluated the functionalities with a
risk assessment based on the impact to the three core criteria: patient safety, product quality and data integrity and
defined the testing strategy.
 Experience in Data Migration, Periodic Review, GAP Analysis, and Risk analysis, FMEA and Remediation Process.
 Implemented GxP (GMP, GCP, and GLP) and GAMP guidelines in the systems.
 Performed TMV’s for Visual Inspection dimensional measurements.
 Preparing a Data Migration Summary Report stating the data migration activities taken place while loading the static
data in the LIMS application. 
 Involved in preparation and documentation for all aspects of the computer system validation to ensure compliance in
accordance with cGxp (cGMP, cGLP and cGCP) and FDA rules and regulations.
 Drafting the Requirement Traceability Matrix document to track the URS and FRS are fulfilled by executing the OQ
and PQ scripts. 

Catalent Pharma Solutions, St. Louis, MO May 2014 – Dec 2015

Validation Engineer
Catalent Pharma Solutions is using to try to ensure its customers' success. The company provides
Contract development and manufacturing of oral (soft and hard shell capsules), topical (ointment applicators), sterile
(syringes), and inhaled (nasal sprays) drug delivery products to pharmaceutical and biotechnology companies.
Responsibilities:
 Provide proper Validation Rationale and Methodology input which brought department up to date on all
cGMP training requirements.
 Responsible for performing quality reviews of CSV deliverables (validation strategy documents, validation protocols,
traceability matrices, & summary reports) in support of a Consent Decree remediation project in a waterfall
environment for a pharmaceutical manufacturer.
 Performed Computer System Validation Risk Assessments 
 Responsible for the review and approval of all Validation Protocols related to equipment, systems, utilities,
sterilization, cleaning, computer and aseptic processes.
 Involved in Reviewing and approving Process Validation Protocols (IQ/OQ/PQ) for UF/DF, Chromatography,
Fomenters, Homogenizers, Centrifuges, Autoclaves, Process Piping, Refrigerators, Freezers, Automated CIP
Skids, Facility, Incubators and WFI.
 Pre-approve test sets and post-approve test runs for Batch Records (BRs) in HP Quality Center.
 Generation of Requirements Traceability Matrix (RTM) and Validation, Test Summary Report (VSR, TSR)
documentation.