Simardeep Kaur

Simardeep Kaur Email and Phone Number

Associate Director @ PPD (part of ThermoFisher) | Pharmacovigilance Specialist | Computer System Validation Specialist| Quality Management| Project Management | Certified SAFe 5 Practitioner | Foundation SCRUM Certified @ Thermo Fisher Scientific
waltham, massachusetts, united states
Simardeep Kaur's Location
Gurgaon, Haryana, India, India
About Simardeep Kaur

Experience in Computer System validation, Project Management and Quality Assurance, Currently I m spearheading as Pharmacovigilance and computer system validation (CSV) leader at PPD, a global contract research organization that provides drug development and lifecycle management services. As an Associate Programming Director, I oversee the implementation and validation of various safety systems for clinical trials, ensuring compliance with regulatory standards and client requirements.I have extensive experience in gathering and documenting business, stakeholder, and system requirements, applying agile methodologies and software testing best practices, and coordinating cross-functional teams and customer interactions. I hold multiple certifications, including ISTQB, SCRUM, and SAFe 5, that demonstrate my proficiency and professionalism in the field. I am also a pharmacovigilance subject matter expert, with in-depth knowledge of the domain and the industry. I am passionate about delivering high-quality solutions that enhance patient safety and advance scientific discovery.

Simardeep Kaur's Current Company Details
Thermo Fisher Scientific

Thermo Fisher Scientific

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Associate Director @ PPD (part of ThermoFisher) | Pharmacovigilance Specialist | Computer System Validation Specialist| Quality Management| Project Management | Certified SAFe 5 Practitioner | Foundation SCRUM Certified
waltham, massachusetts, united states
Website:
thermofisher.com
Employees:
53105
Simardeep Kaur Work Experience Details
  • Thermo Fisher Scientific
    Associate Programming Director
    Thermo Fisher Scientific Apr 2023 - Present
    Gurugram, Haryana, India
  • Ppd
    Optimization Principal
    Ppd Jul 2022 - Mar 2023
  • Accenture
    Associate Manager
    Accenture Oct 2020 - Jul 2022
    Gurugram, Haryana, India
     Managed implementation of different Safety systems through the phases discovery, design, development, QA testing (Qualifications Protocols), post go-live maintenance support, as a project manager  Attending system workshops during the discovery phase, finalizing and customizing the system functionalities for business use.  Preparing the project roadmap, Project Plan, Validation Plan, Disaster Recovery Plan and other project deliverables  Collaborated with cross-functional teams managing multiple commitments  Interacting with business team to finalize the system requirements and configurations. Working with team to document the system specifications Identify the functionality gaps and delta features Coordinating the requirement risk assessment  Creating the Validation Plan and strategy.  Co-ordinating with the QA team for validation approach, SOP creations, Scripting the PQ, Review PQ, Execution review of the PQ. Preparing the Validation Summary Report, Traceability Matrix and Defect Management Handling change management for the system implementation and project closure activities Managing the system Go-live and Hypercare as validation coordinator
  • Deloitte Consulting
    Senior Consultant
    Deloitte Consulting Aug 2017 - Oct 2020
    Gurgaon, India
     Currently working as Business Analyst and SME in leading Pharmaceutical Company Pfizer.PROFESSIOANL PROJECT EXPERIENCE DETAILS: • Extensive knowledge of Argus Safety 8.0.x Configuration and Database.• Working as the Subject matter expert for Argus Safety upgrade to 8.0.x.• Analyzing requirements, determining whether the stated requirements are clear, complete, consistent and unambiguous, and resolving any apparent conflicts.• Reviewing, and documenting requirements and specifications BSRS (Business and Stakeholder Requirements Specification) for the Argus upgrade.• Finalizing requirements and drafting Functional requirement i.e. SRS (Solution Requirements Specification)• Creating Trace ability Matrix document for BSRS, SRS and Test scripts.• Participate in the review meetings and preparing the quality check processes/documents to make sure that the Quality of the deliverable is high.• Issue tracking, follow up and resolution.• Planning for the Test implementation and execution phase.• Managing and mentoring team in offshore to meet the expected deliverable.Ensure that the quality systems, follow the Good Practice (GXP) for all the deliverable.• Prepared white papers for the organization on Genilogix eAapprove add-in in Quality Center, Computer System Validation Process and Argus Safety Configurations
  • Deloitte Consulting
    Consultant
    Deloitte Consulting Sep 2014 - Sep 2017
    Gurgoan
  • Deloitte Consulting
    Bta
    Deloitte Consulting Jul 2013 - Sep 2014
    Gurugram, Haryana, India
  • Wipro Technologies.
    Senior Test Engineer
    Wipro Technologies. Jan 2010 - Jun 2013
    Expertise with Manual Testing, Risk Based Testing, SDLC, STLC, Requirement and Process Management.In-depth knowledge and experience in various testing approach like System testing, Regression Testing, End to End Scenarios testing, Negative and Positive testing, Smoke and Sanity testing.Expertise in handling database testing using AQT Application.Expertise in working with HP QC 9.2/10Basic SQL Knowledge.Basic knowledge of QTP, mainframe screen navigation and Database. Involved in Interaction and Support of development teams. Good Domain knowledge of BFSI ( Banking and Finance ) and expertise in working withCore banking sectors worked on are Retail, Internet Banking and Mobile Banking.Sound knowledge of Industry standards and software engineering processes.Excellent analytical and logical skills with strong writing and verbal communication skills.Experience and learning and facing real challenges while working on Live projects with Line of business of bank.

Simardeep Kaur Education Details

Frequently Asked Questions about Simardeep Kaur

What company does Simardeep Kaur work for?

Simardeep Kaur works for Thermo Fisher Scientific

What is Simardeep Kaur's role at the current company?

Simardeep Kaur's current role is Associate Director @ PPD (part of ThermoFisher) | Pharmacovigilance Specialist | Computer System Validation Specialist| Quality Management| Project Management | Certified SAFe 5 Practitioner | Foundation SCRUM Certified.

What schools did Simardeep Kaur attend?

Simardeep Kaur attended Thapar Institute Of Engineering And Technology, Sacred Heart School Chandigarh, Loreto Convent Lucknow.

Who are Simardeep Kaur's colleagues?

Simardeep Kaur's colleagues are David J. Rodriguez, Ouissale Berg, Kimberley Plummer, Iain Chalmers, Giorgio Calvi, Urtė Zabielskaitė, Michael (Ify) Ntoka.

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