Senior Business Architecture Analyst with more than 6+ years of experience in IT Compliance and Quality Assurance for the Life Sciences industry, currently in the role of Business Architecture Senior Analyst for Accenture Life Sciences, India. successfully supported and facilitated multiple regulated software solutions for large drug manufacturing and R&D companies like USV, Lupin, Biocon, Astellas, NovoNordisk to name a few and also have experience in testing for Heavy Machinery industry solutions.
I have hands on experience in authoring validation deliverables and knowledge of various QMS tools and processes, have supported and led multiple validation, corporate audits and conducted periodic review.
Have Hands on experience in setting up & building Quality Management System, defining process, End to End Validation, training personnel on LS industry requirements.
Accenture – Senior Compliance Analyst , Offshore, Operation and Maintenance Project (2023-2024)
· Supported O&M reporting activities and Authored User Review Report and Periodic Evaluation reports across different regions.
· Reported challenges part of the process and provided resolution to streamline and mitigate issues.
· I was part of the automation project team (Continuous Solution Monitoring) as a core product member involved in improving and releasing the solution as per industry best standards and end user requirements.
Accenture – Senior Compliance Analyst, Offshore, Veeva CRM Consolidation Project (2022 – 2023)
· Supported and reviewed cloud and SAP S/4 HANA solutions validation project for global roll out.
· Conducted GxP Classroom training for new joiners and training sessions on latest pharma trends and importance of process adherence and compliance requirements.
· Authored & Reviewed CSV deliverables like MVP, Project Plan, Regulatory Assessment and system categorization, BPD, URS, FRS, Risk Assessment, Design specification, VP, TP, TM, IQ, OQ, PQ, TSR, Periodic Evaluation Report, VSR, Decommissioning Plan/Report.
· Provided guidance on Risk assessments and organizational process for various project activities.
· Mitigation and resolution of defects / anomalies found during testing phase and deviation handling as per client process and QA.
· Supported the data migration activities and in defining rules for data migration verification and documentation of data migration report for various region part of the project.
Accenture – Compliance Analyst Offshore, Business As usual – EMEA Project (2021-2022)
· Drive weekly status meeting and discuss compliance issues and challenges with stakeholders.
· Reviewed and updated CAPA/Deviation/Justification report for major deviations and incidents.
· Supported and involved in process improvement for Harmonization of CSV.
•Involved in setting up validation activities and CSV process for 100 + Equipments.
•Authored and ensured approvals for all the GxP / CSV lifecycle deliverables.
•Ensured timely and accurate business delivery is followed.