Nikita Kumari

Operations Associate

Ghaziabad, Uttar Pradesh, India19 yrs 4 mos experience

Most Likely To SwitchHighly Stable

Key Highlights

Over 9 years in Pharmaceutical compliance.
Expert in SAP and GxP regulations.
Certified Auditor for Information Security Management.

Stackforce AI infers this person is a Healthcare Compliance Specialist with extensive SAP expertise.

Contact

Skills

Core Skills

CsvSap ComplianceSap Qm ImplementationQms ComplianceSap ImplementationTraining

Other Skills

QA ComplianceSAPDocumentumTrackwiseRemedySAP QMQMS21 CFR Part 11GAMP 5ConfigurationUnit testingEnd User TrainingMIS ReportingSAP R/3Master Data

About

• • Experienced professional in Pharmaceutical and healthcare compliance domain with wide experience in GXP, 21 CFR part 11, GAMP 5 and other compliance requirements and adherence. • Specialist in Life Sciences IT Compliance/CSV with extensive experience in FDA (GxP, 21 CFR Part 11), and other regulations. • Over 09 years of experience in providing tactical direction and guidance for project teams implementing Computer Systems for new or existing GxP systems including the development and analysis of system requirements. • A Manager production/Quality with over 8+ years of rich experience in Operations & Maintenance, Process Management, Resource Management & Quality Assurance for Electrical and Electronics Equipment’s. • Wide exposure in ERP SAP implementation in Pharmaceutical, FMCG healthcare Manufacturing, IT infrastructure, OIL Exploration, Software Product development industry by having executed SAP Implementation, Validation and Maintenance projects to comply with regulatory requirements. • Seasoned professional in Validation activities related to Quality systems, Lab Systems Validation, IT Infrastructure Validation, and Supply chain Validation, Quality systems and service desk compliance. • Certified Auditor from BSI training Academy for Internal Auditor Training for Information Security Management System (BS/ISO/IEC 27001:2013) • Lead and worked at onsite (Canada) and offshore locations with diverse teams spread across various physical locations. • Extensive experience in project of SAP and full life cycle implementation ERP’s.

Experience

19 yrs 4 mos

Total Experience

4 yrs 10 mos

Average Tenure

14 yrs

Current Experience

Sun pharma

2 roles

Senior Manager

Mar 2015 – Present · 11 yrs 2 mos

Enterprise wide CSV/QA Compliance for the whole IT estate which includes SAP,LMS, Stability ,Documentum, Trackwise, Remedy, Backup tools, Standalone equipment’s, Global Business Support Projects and Infrastructure applications
Lead the Global SOP and IT compliance and Rollout for all Ranbaxy Locations including training and effectiveness. Part of the core team responsible to Design, develop, and implement compliance, risk and audit policies in the organization.
Responsible for SAP Landscape compliance and Audit for entire organization.
Mentor the site CSV/QA resources, project consultants and CSV/QA teams for projects.

CSVQA ComplianceSAPDocumentumTrackwiseRemedy+1

Senior Manager

May 2012 – Present · 14 yrs

Enterprise wide CSV/QA Compliance for the Global IT System, R&D IT System which includes SAP,LMS, Stability ,Documentum, Trackwise, Remedy, Backup tools, Standalone equipment’s, Global Business Support Projects and Infrastructure applications
Lead the Global SOP and IT compliance and Rollout for all Ranbaxy Locations including training and effectiveness. Part of the core team responsible to Design, develop, and implement compliance, risk and audit policies in the organization.
Responsible for SAP Landscape compliance and Audit for entire organization.
Mentor the site CSV/QA resources, project consultants and CSV/QA teams for projects.
Worked on the interface of Global Vendor Management System and SAP
Developed and Validated MIS reports for approve Vendor and Manufacturer
Managed testing for all SAP applications. ITSM (BMC remedy),Documentum, Trackwise, LMS and standalone equipment.

CSVQA ComplianceSAPDocumentumTrackwiseRemedy+1

Ibm india pvt. ltd

Senior Consultant

Jun 2011 – May 2012 · 11 mos · Noida Area, India

SAP QM Implementation:
Lead the SAP QM Module team, understanding of SAP QM in their business scenarios.
Gathering business requirement. And visited to Draxis Montreal Canada and Anrak Aluminum Pvt. Ltd.
Ensure compliance to QMS, 21 CFR Part 11, GAMP 5 practices
Analyzing Standard SAP requirements, customizations (Non Standard solutions) and non-sap solutions.
Configuration in SPRO and Unit testing, and integration testing with other modules.
Creation of Document info Records in QM and integrate it with QM
Objects i.e. inspection type, inspection lot, Notification, MIC, Inspection
Method, sampling procedure, Sample drawing procedure, Class and Classification.
Core user Training- Unit Testing, Integration testing, User Acceptance testing, Master Data Template

SAP QMQMS21 CFR Part 11GAMP 5ConfigurationUnit testing+2

Accenture services pvt. ltd

Team Lead

Oct 2009 – Jun 2011 · 1 yr 8 mos

SAP QM Implementation:
Lead the SAP QM Module team, understanding of SAP QM in their business scenarios.
Gathering business requirement for Cardinal PET Pharmacy 35 PET plants and HPCL Mittal Energy Ltd.
Ensure compliance to QMS, 21 CFR Part 11, GAMP 5 practices
Analyzing Standard SAP requirements, customizations (Non Standard solutions) and non-SAP solutions.
Configuration in SPRO and Unit testing, and integration testing with other modules.
Creation of Document info Records in QM and integrate it with QM
Objects i.e. inspection type, inspection lot, Notification, MIC, Inspection
Method, sampling procedure, Sample drawing procedure, Class and Classification.
Core user Training- Unit Testing, Integration testing, User Acceptance testing, Master Data Template

SAP QMQMS21 CFR Part 11GAMP 5ConfigurationUnit testing+2

Bhushan steel & strips ltd.

Manager SAP

Jan 2007 – Oct 2009 · 2 yrs 9 mos · Ghaziabad

Conduct End Users training at different phases as per training calendar
Regular interactions and meetings with Process Owners, HODs and key end users for their inputs, feedbacks and actions.
Worked in the SAP Implementation Roll out in sister concern.
Developed many customized report for supporting the Management for MIS report.
Additional major responsibilities were MR –Management representative.
Trouble shooting as and when required by the End Users and supported

SAP ImplementationEnd User TrainingMIS ReportingTraining