Project Quality Assurance

Uma Illapani

(***)- ***-****

Email: ***.********@*****.***

SUMMARY

. MBA with 5 + years of diverse experience in Pharmaceutical Industries

with 21 CFR Part-11 Validation, Software Development Life Cycle (SDLC)

& Quality Assurance

. Solid Understanding of the following Pharmaceutical Concepts -FDA

regulations, 21 CFR Part & Clinical Trials

. Extensive experience in gathering Business and Functional

Requirements, developing Use Cases, conducting Risk Analysis, GAP

analysis and 21 CFR Part 11 checklists and assessments.

. Expert knowledge in the preparation and execution of IQ, OQ, PQ/UAT

protocols.

. Experience in all phases of the Project Life Cycle (PLC) and Software

Development Life cycle.

. Proficient in development and re-engineering of Standard Operating

Procedures.

. Experienced in prospective, retrospective and periodic evaluation

processes.

. Good experience in developing and executing of Test Plan, Test Cases,

and Test Scripts.

. Excellent knowledge and working experience in with test planning, test

execution and test results analyses

. Working experience in validation of Lab Instruments (HPLC,FTIR,UV),

. Experience in validation and qualification of instrument interface

process to Laboratory Information Management System(LIMS)

. Experience in Quality review of Validation deliverables for Adverse

Error Reporting (AERS), LiveLink and SAS Systems

. Strong experience in the technical writing related field.

. Demonstrated strong SDLC experience, as well as a proven ability to

manage the lifecycle of technical document development from inception

through publication with a high degree of quality assurance

. Strong ability in development of a variety of regulatory deliverables,

including validation plans, protocols, and reports, risk analysis,

audit documents, data migration plans, and procedures

. Familiar with Good Documentation Practices (GDP).

. Experienced with MySQL, Microsoft Access, Excel, Word, Power Point,

Outlook, and Adobe Photoshop.

. Excellent communication and presentation skills, self starter, quick

learner, team player

. Strong Analytical and Problem Solving skills, Multi-Tasking abilities,

with proven experience in utilizing people and process knowledge to

assist enterprises in making critical decisions

. Proven ability to contribute significantly to projects independently

and in a team environment

EDUCATION

. Masters in Business Administration, USA

. Bachelors of Science, India

. Diploma in Computer Applications

EXPERIENCE

March 2010 - Current

Valeant Pharmaceuticals, Inc, CA

Validation Engineer

1. Ensured quality and regulatory compliance across Valeant's IT

Department

2. Involved in providing Quality Management support for Computer System

Validation as per FDA guidelines, Corporate policies for GLP, GMP and

GCP systems

3. Reviewed and provided guidance on Project plans to ensure an approach,

to satisfy corporate and regulatory is clearly defined

4. Reviewed and provided quality guidance on SDLC deliverables including

Project Plan, Requirements Specifications, Design Specifications, Test

Plans, System/UAT/IQ/OQ/PQ Test Cases, Test Summary Reports,

Retirement Plans, and Change Control Plans.

5. Provided quality guidance to manage changes to computer systems in a

controlled and efficient manner

6. Conducted Compliance Reviews for the existing open change control

requests for Adverse Error Reporting (AERS), LiveLink and SAS Systems

to ensure process alignments and close them appropriately

7. Conducted Periodic reviews for existing systems and standard operating

procedures

8. Assisted in the development and revision of global computer systems

validation (CSV) processes, policies, and standards

9. Provided document management support to collect and archive project

deliverables to Records Management archives

10. Provided guidance to the Project Teams in understanding and addressing

the Part 11 requirements for each system

11. Worked with the Quality Management group to update/prepare various

templates used to implement the SLC process

12. Interacted and coordinated with various Shared Services departments to

support projects

May 2005- August 2009

Baxter BioScience, CA

Validation Lead

ePedigree Project

13. Involved in Quality Analysis and Risk Assessment for the ePedigree

System.

14. Involved in Quality review of the Project Validation Deliverables for

Baxter Corporate, Bioscience and Manufacturing facilities

15. Planned, organized, analyzed, and interpreter technical specifications

prepared by engineers to determine appropriate content for

documentation

16. Wrote user-friendly, original documentation for updates and

modifications.

17. Ensured strict compliance with standards and templates in relation to

the writing of technical documentation.

18. Submitted drafts of technical material for customer review and managed

edits.

19. Verified the clarity, completeness, accuracy, and quality of all

technical documentation.

20. Confirmed subject knowledge through feedback of cross-functional

sources.

21. Prepared and distributed ad hoc and urgent documents for the ePedigree

project.

22. Reviewed requirements for testability and usability, consulted

development staff with regards to system functionality

23. Involved in generating and closure of Change control documentation.

24. Involved in creation of SAT (Site Acceptance Testing), URS, FSDS, Risk

Assessment and Trace Matrix templates to be used at various Baxter

sites.

LIMS PCR Pooling Project

25. Involved in creating and reviewing of validation deliverables for LIMS

PCR Pooling process at the Baxter BioLife Facility.

26. Involved in preparation of Project charter and Feasibility Plan.

27. Involved in documenting the business process by identifying the

requirements and also involved in finding the system requirements.

28. Participated in meetings with Quality department and Project managers

and understood various process plans, business process, and

functionality in detail.

29. Involved in designing the Change Control System at Baxter BioLife

Facility to meet with Baxter Divisional Quality standards.

30. Developed change control SOPs and forms for Change Control System at

Baxter BioLife Facility.

31. Work with Global Process and QA Coordinator to provide mentoring to

team members on the principles of developing proper lifecycle

documentation.

32. Expertly determine the gap between documented requirements and

functionality of legacy applications and technical design

specifications with an emphasis on current requirements and

functionality.

33. Ensure application requirements are captured within the CDS test

management tool.

34. Verify the development of tractability matrices to link requirements

to test cases.

35. Employ the use of existing documentation and high-end software

engineering techniques.

36. Implement the use of standard templates to create up-to-date SDLC

documents.

37. Supervise the appropriate review, approval, and completion of all

steps.

Global LIMS Project

Responsibilities:

38. Involved in validation and qualification of instrument interface

process to Laboratory Information Management System developed by

Applied Bio Systems, Inc via LimsLink application developed my

Labtronics, Inc.

39. Coordinated Instrument interfacing process for different Baxter sites

in North America and Europe.

40. Involved in interfacing Laboratory instruments like HPLC,

Spectrophotometers, Climet Particle Counters, Ph Meter, Conductivity

meter etc at different Baxter sites to LIMS using LimsLink

application.

41. Interacted with users, site admins, and system owners for gathering

information on the laboratory workflow/business process for various

instruments.

42. Developed User Requirements Specification (URS), Functional

Requirements Specification (FRS) & Configuration Specification (CS)

documents for the instrument interfacing system.

43. Authored and executed qualification documents for Global Instrument

Interfacing project

44. Documented Final Test Summary Reports and developed Requirement

Traceability Matrix

45. Coordinated with Validation Manager and Quality Personnel for document

approvals.

46. Developed the PQ, IOPQ, and IOQ templates for site implementation at

various Baxter sites.

47. Coordinated with the vendor to resolve any issues regarding the

interfaces and performed consecutive testing.

48. Contributed to new project related SOPs and revised existing SOPs

49. Developed training materials and performed training on the Limslink

overview for the Lab Analysts at various Baxter sites.

50. Involved in validation of SQL*LIMS including preparation of protocols

(IQ, OQ, PQ)

51. Developed Functional Design Specifications for new forms and reports

developed within SQL*LIMS.

52. Performed testing for new forms and reports within LIMS and reported

the bugs to the developers.

53. Designed and executed test procedures to validate the most utilized

SQL*LIMS forms and reports.

54. Participated in various meetings and was involved in the discussion of

enhancement and modification request process

55. Interacted and coordinated with various Shared Services departments to

support projects.

July 2004- April 2005

Wyeth Pharmaceuticals, Inc., NY

Validation Consultant

56. Worked on Computer Systems Validation according to company validation

policies to ensure 21CFR Part 11 compliance.

57. Prepared Validation Protocols, Installation Qualification, Operational

Qualification, Performance Qualifications for Shimadzu LC-10Ai HPLC

and Shimadzu 8300 FTR spectrometer

58. Involved in writing Remediation documents in compliance with 21 CFR

Part 11 guidelines for laboratory instruments

59. Documented User Requirements Specification document and Functional

Requirements Specification document.

60. Involved in Technical writing of test plans and execution of Protocol

61. Developed the Requirement Traceability Matrix (RTM) and involved in

preparing the test summary report

62. Documented Test Summary Report and Validation Summary Report

63. Involved in performing the Analysis of the current system and

preparing Remediation Plan

64. Interviewed system users, QA personnel for gathering information for

functional, regulatory, 21 CFR Part 11 and configuration requirements

65. Routed the documents to project lead, QA and peers for review and

approval

66. Strictly followed technical writing procedures while executing the

documentation

Contact this candidate