Quality Data
Resume:
Kritika Hans
CSV Consultant
Expertise in Quality Assurance and Regulatory Compliance
consultancy at Life Sciences & Health Care (LSHC) Fortune 500 organizations – FDA 21 CFR part 11, 820.30, and EU directives/Annex 11 through Computerized System Validation (CSV) across ERP, Web Application, and Mobile Applications for Clinical Reporting and Research and Development.
E-mail - adi91v@r.postjobfree.com
H.no 356, Sector 22,Gurugram, India
linkedin.com/in/kritika-hans-96bb0ba4
WORK EXPERIENCE
Validation Lead
ZS Associates/ Gurugram
05/2019 – Present
Achievements/Tasks
• Responsibilities: Working as a Validation Lead
aiding team management and validation of life science project.
• Performing BQR activities as well by assisting in Regulatory Assessment, System Criticality
Assessment and GxP Assessment.
• Identifying risk by performing Risk Assessment and socializing them via Raid Log.
• Reviewing and understanding system and business
requirements and aid identifying the gaps.
• Feature FMEA- create validation procedures based on failure modes.
• Subject Matter Expert
on SDLC/Qualification procedure and able to provide guidance to IT and/or Business.
• Participate on cross functional teams to
validate/verify, implement, and maintain regulated
(Example: GxP.) and/or non-regulated systems.
• Lead the validation/verification/qualification
strategy by either working with the offshore testers to develop the test strategy or develop the strategy, then obtaining approval from the business and/or IT.
• Work with project team’s offshore testers and
ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
• Ensure the project testing timeline is met per
specified agreement and/or scope change.
• Understands the various testing activities: Unit, System, Component, User Acceptance,
Performance, Integration and Regression.
• Thoroughly understands the difference
between Positive versus Negative Testing.
• Support testing in either an IT or Business area, ensuring compliance with all company and
departmental policies, procedures and standards.
• Analyze test results and ensure requirement objectives and documentation standards have been met.
• Insure all SDLC deliverables are completed and have stored appropriately
• Leads resolution efforts when issues are identified and escalate appropriately.
• Actively share emerging industry standards/trends with customers and peers within area of responsibility
• Support the response and remediation of corrective actions and internal audits
SKILLS
DELIVERED PROJECTS
• Boehringer Ingelhiem (06/2015 – 10/2017)
Validation of Clinical Data Reporting and SAS based project. Validation of Global Medical Information
Management System
• Sanofi (10/2017 – 10/2018)
Validated multiple ERP, platform based and web application project. Many new engagements achieved and got onsite collaboration
• Philip Morris International (11/2018 – 03/2019)
Validation Clinical Data and Trail Data Analysis
Application New projects achieved with client
appreciations
• KPMG-Internal SOD System (11/2018 – 05/2019)
Validation of Mobile Application
Proposals Accepted by big pharma manufacturing companies
• Medidata RAVE (05/2019 – 08/2020)
iMedidata RAVE – Clinical Data Repository
iMedidata Authorizations Checks and Audit rail
• JIRA Implementation (05/2019 – 08/2020)
Validation of JIRA implementation
Validation of project management and workflows
GXP Assessment
Doors and ALM
21 CFR Part 11
ISO 13485
Clinical Domain SME
Risk Assessment
Annex 11
ISO 14971
HP QC
21 CFR Part
820
GAMP 5
GAP & Risk Analysis OLA and Service LA
• Cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks
• Proactively identify and assist in prioritizing
opportunities to streamline testing and/or quality but still stay compliant
Senior Test Engineer
INCEDO / Gurugram
05/2019 – 08/2020
Achievements/Tasks
• Responsibilities: Working as a Quality Analyst
aiding on quality procedures to be taken care of while validation. Authoring Test Plan, gathering information from development team, Development Report and
Installation qualification reports, Authoring and
Execution of Test Scripts and providing Test Summary Report.
• Participating in Audit process and compliance
checks
• Assisting in Validation activities, Migration
activities reports
• Different type of testing – Migration, ETL,
Performance, Functional testing, Dashboard
and data validation
• Internal Compliance Audits and Self
Inspection
• Validation of Commercial and Clinical
Applications
• Validation of SAMD and Medidata Rave
• Medidata certified Clinical Research
Coordinator
Risk Consultant
KPMG/ Bangalore
11/2018 – 05/2019
Achievements/Tasks
• Responsibilities: Preparing Project Proposals and Engagement Letter. Performing quality checks and
client reporting while end-to-end SDLC. Creating
Validation Plan, Functional Risk Assessment, Test
Strategy and Summary Report. Documenting
Requirement Traceability Matrix and Release
documents like Authorization for User and
Conformity Certificate.
• Handle Change Management Process including
Change Request and Change Summary creation.
Documenting Test Protocols (IQ, OQ and PQ),
performing review and approvals. Organizing project level gatherings and annual client meet.
• Service and Operational Level Agreements
• Achievements: Successful engagements,
organizational awards and client appreciation.
Process Improvement and value-added ideas which
helped 20% of the client cost. Six Sigma Certification
• SOP, involving in gathering of User Requirement
Specification. Performing System Criticality
Assessment, GxP Assessment and Risk Analysis.
Documenting Validation Package.
• Bristol Myers Squibb - CDR-SCE System (08/2020 – Present)
Validation of study data, files and folders ingested from CDW and data egress. Validation the system UI, different user roles and study data ingested.
QA Tester
TCS/ Gurugram
02/2015 – 10/2018
Achievements/Tasks
• Responsibilities: Develop and execute test plans to ensure that all objectives are met.
• Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the service or product.
• Identify and remedy defects within the production process.
• Recommend, implement, and monitor preventative and corrective actions to ensure that quality assurance standards are achieved.
• Compile and analyze statistical data.
• Ensure that user expectations are met during the testing process.
• Draft quality assurance policies and procedures.
• Investigate customer complaints and product issues.
• Ensure ongoing compliance with quality and industry regulatory requirements.
EDUCATION
BCA
Guru Nanak Dev University
03/2011 – 03/2014 Amritsar, Punjab, India
MBA
Swami Vivekanand Subharti University
03/2018 – 06/2020 Meerut, UP, India
Language
Hindi, English
Efficiency – Like bilingual language
ACHIEVEMENTS
Cost Saving
Value Added Idea provided which were implemented by placing common document repository system and saved 20% cost of the client
New Engagements
By dedication and smart working, achieved new engagements and client appreciations.
Awards
I have been awarded with ‘Game Changer’ label in my current organization. I have also been awarded and recognized throughout my experience starting from quick learner to star of the month.
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