Anila Chintalapati

9039522586
anilacpati@gmail.com

PROFESSIONAL SUMMARY:
Senior CQV Engineer in Healthcare industry in Commissioning, Qualification and Validation (CQV) for all aspects of the equipment,
utilities, and manufacturing setup. Excellent experience in performing CSV for softwares associated with equipment. Responsible for
scheduling, planning and execution of validation projects for plant utilities, facilities, and process equipment. Experienced in
Qualification protocol generation, execution, and writing final reports for various new and existing systems, equipment, and
facilities. Wrote/revised SOPs and other quality documents and perform equipment requalification based on pre-determined
intervals, recent changes and modifications made to the systems per approved change control requests. Excellent experience in
Temperature Mapping.

PROFESSIONAL EXPERIENCE:

AstraZeneca, TX
Sr. Validation Specialist Jan 2019 – Present
Responsibilities:
 Developed critical validation lifecycle documentation to support the qualification/validation of equipment, processes, and
utilities (IQ, OQ and PQ protocols, Operational SOPs, PM SOPs, Change Controls, User/Functional/Design Specifications)
 Developed and executed validation protocols, coordinated system and equipment documentation collection, and execution of
protocols.
 Performed Temperature mapping using Kaye validator and Data loggers.
 Scheduled Preventive Maintenance and Calibration for equipment.
 Used Asset Management systems as BM RAM (Blue Mountain) and Maximo for maintaining and tracking Calibration and
Preventive Maintenance of equipments.
 Qualified Freezers, Ovens, Incubators and Autoclaves.
 Developed technical SOW documents and estimate time and resources needed for projects.
 Solved qualification and validation execution issues using critical analysis skills; ensures alignment with client directives and
industry guidelines on validation.
 Ensured validation and qualification activities of products, processes, methods, facilities, utilities, and equipment comply with
internal requirements and applicable regulations and standards.
 Performed validations (DQ, IQ, OQ, PQ, MSA) by creating and executing protocols.
 Compiled statistical data and write narrative reports summarizing quality findings.
 Applied thorough understanding of cGXPs, relevant plans and SOPs, routine project procedures, project management, and other
training as appropriate.
 Performed variety of CQV projects/studies in areas including Cleaning verification and Equipment commissioning and
qualification, as well as projects/studies to support manufacturing.
 Planned CQV projects and track execution of CQV activities/documentation versus project timeline. Manage and plan work of
the internal and contract resources.
 Performed change control assessments and write/review CQV plans, study/test protocols, and summary reports. Managed
execution of study/test protocols and review test results.
 Ensured consistent coordination and implementation of changes to GMP facilities, utilities, equipment, computerized process
control and information systems, as well as controlled documents.
 Involved in sampling and testing of the Purified water, Compressed Air and Clean Steam Systems
 Performed the Facility Performance Qualification for the Quality Control lab in accordance with monitoring limits and current
Good Manufacturing Practice (cGMP)
 Collaborated closely with Engineering and Process sciences in defining the role of suppliers with the assessment of suppliers and
oversight of supplier activities and documentation related to Commissioning activities.
 Performed CIP and SIP studies.
 Base line the test plan, test criteria & Project Schedule by walkthroughs and reported the defects using HPALM.
 Conducted UAT (User Acceptance Testing) to make sure that all the user requirements are created by the application and
constantly redesigned the system to increase its user friendliness for the clients. 
 Performed GAP Analysis and developed the corresponding Remediation plan. 
 Authored various Validation Deliverables like Test Plan, Test Summary report and Final Validation Report maintaining company
standards.
 Designed engineering studies for new equipment. 
 Executed Engineering Studies and writing Final Reports for Engineering Studies
Anila Chintalapati
9039522586
anilacpati@gmail.com

 Performed all phases of end-to-end testing like User Acceptance Testing, Functionality Testing, Regression Testing, GUI Testing,
Negative Testing, System Testing
 Developed and Maintained the Requirement Traceability Matrix (RTM) to check the system fulfil all requirements.

Haemonetics, UT
Validation Engineer Jun 2017 – Dec 2018
Responsibilities:
 Created and executed commissioning and qualification protocols/test plans for facilities, utilities and equipment using a risk-
based approach.
 Implemented and coordinated commissioning and qualification of manufacturing equipment and computer systems for use in
regulated and non-regulated operations.
 Developed and executed IQ, OQ, PQ documents, UAT, FAT, SOPs, and Engineering Change Requests
 Prepared IQ, OQ, and PQ protocols for new or modified manufacturing equipment, processes, systems, facilities, and Utilities.
 Performed temperature mapping studies and calibrations using Data loggers.
 Worked with external vendors on calibrating some critical parameters and managing certifications.
 Drafted SOP’s for Preventive maintenance techniques for various equipment.
 Performed Investigations and Root Cause Analysis and troubleshoots for various equipment and process related issues.
 Hands on Windchill Asset Management system for maintaining Equipment Calibration Records.
 Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action
(CAPA), STAT testing and drafting Remediation Plans for the project management approval after the GAP Analysis.
 Developed detailed Project Plan, reviewed User Requirement Specifications (URS) and Functional Requirements Specifications
(FRS)
 Authored and reviewed cleaning validation protocols and reports. Developed Cleaning validation Matrix with worst case
cleaning techniques.
 Authored commissioning and qualification of CSV documents through system life cycle. This includes deliverables such as user
requirements, functional/design specifications, qualification protocols, reporting, and support documentation.
 Reviewed laboratory requirements and define procedures for instrument and data management/data integrity.
 Implemented 21 CFR Part 11 for new and existing testing computerized laboratory instruments, perform gap assessments and
define resolutions in compliance with cGMP requirements.
 Supported installation activities when needed to ensure proper systems startup and recommend changes to improve system
design.
 Regularly interacted with external development partners and equipment suppliers, Quality, and IT group.
 Created equipment and process specification documentation 
Conduct field inspections including piping and equipment walk downs, operational startup and troubleshooting. 
 Developed risk assessment, system impact assessments and validation plans. 
 Investigated deviations and write investigation report.
 Reviewed, analyzed, and interpret system performance data for completed qualification and prepare final package to
summarize data. 
 Responsible for maintaining Quality System Regulations including Document Control and Record Control.

Insulet, MA
Validation Engineer Apr 2015 – May 2017
Responsibilities:
 Created and executed validation and revalidation protocols and reports, (IQ/OQ/PQ), for the validation of new and existing
processes, equipment, systems, etc.
 Performed Calibrations, PM’s, EHS as a part of Equipment Qualification.
 Validated Lab Equipment and scheduled PM’s and Calibrations.
 Prepared and issues work instructions/layouts related to product changes or new products, processes or methods specifying
sequence of operations and standard work for manufacturing process.
 Reviewed and approved the new design and process prior to release to the production floor.
 Participated in design reviews; inspection of prototypes; final sign-off on new products.
 Developed summary reports, following good documentation practices.
 Validated the Platter fixtures which are used to test the failure of the products manufactured in the surveillance lab and CDI 500
Blood Gas Monitor present in the Heart Lung Machine.
 Authored PFMEA’s for the manufactured products.
Anila Chintalapati
9039522586
anilacpati@gmail.com

 Authored Integrated Validation Planning Requirements (IVPR for Validation Plan, SOPs, URS/FRS), Integrated Validation Test
Protocol (IVTP for IQ/OQ/PQ Protocols), TM and Summary Reports.
 Analyzed test scripts to check whether all functionalities have been covered within the compliance of GMP regulations.
 Involved in Method design (re-design) and validation (re-validation).
 Engineered and supported major multiple capital projects as part of continuous improvement teams.
 Involved in selecting best-suited process equipment for applications by meeting vendors and running trail.

EDUCATION: Masters, Information Systems, University of Maryland, USA