Simardeep Kaur Email and Phone Number
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.
Thermo Fisher Scientific
View- Website:
- thermofisher.com
- Employees:
- 53105
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Associate Programming DirectorThermo Fisher Scientific Apr 2023 - PresentGurugram, Haryana, India -
Optimization PrincipalPpd Jul 2022 - Mar 2023 -
Associate ManagerAccenture Oct 2020 - Jul 2022Gurugram, 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 -
Senior ConsultantDeloitte Consulting Aug 2017 - Oct 2020Gurgaon, 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 -
ConsultantDeloitte Consulting Sep 2014 - Sep 2017Gurgoan -
BtaDeloitte Consulting Jul 2013 - Sep 2014Gurugram, Haryana, India -
Senior Test EngineerWipro Technologies. Jan 2010 - Jun 2013Expertise 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
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Electromechanical Instrumentation And Maintenance Technologies/Technicians -
Sacred Heart School ChandigarhHigher Secondary -
Loreto Convent Lucknow
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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Simardeep Kaur
Director/Chapter Leader, Responsible For Bringing Engineering Excellence To The Product Area By Building Technical Expertise For The Squads And Contribute To Product Roadmap In Collaboration With Product Team.Bengaluru1fidelity.com -
Simardeep Kaur
Software Developer | App Developer | Passionate About Creating Impactful Solutions | Open To New OpportunitiesCachar
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