M.D. Malleswari
Narsipatnam
Summary
Dynamic IT Validation & Compliance Specialist with extensive experience at NovoNordisk, excelling in IT compliance and risk assessment. Proven track record in driving qualification strategies and enhancing audit management processes. Adept at collaborating with diverse teams, demonstrating strong communication skills while ensuring adherence to GxP standards and delivering impactful service documentation.
Overview
13
13
years of professional experience
Work History
IT Validation & Compliance Specialist I
NovoNordisk
10.2022 - Current
- Support IT Infrastructure qualification activities e.g., creation and maintenance of the qualification documentation
- Ensuring the Quality and Compliance for the service maintenance with in the GITO C&CI Area Product Area
- Ensuring that IT services are following relevant internal and external requirements
- Work in the agile framework as part of a product team and work towards the team’s goals, based on Product Owner and Business Owner’s requirements
- Defining and executing qualification strategy for IT Infrastructure both in the project and operations phase
- Perform end to end Infrastructure Qualifications qualification activities including Supplier assessment, IT risk assessment, functional and data integrity assessments Implementation plan, Implementation report, Design Review, Test strategy and execution etc
- Serving as Local Risk Manager for GITO C&CI Area
- Work with improvements of the qualification process and the vendor cooperation
- Guide product teams on deviations and Handling Deviation in NovoGlow
- Support Service Manager and Product Owner in creation and maintenance of service documentation and instructions
- Supporting product teams with audits and inspections including closing any identified finding
- Participating in GIA and Internal Audits and preparing Product team for audits
- Train product teams on NN quality and compliance e.g., IT Infrastructure Qualification
- Ability to collaborate and communicate with stakeholders, both internal and external at all levels
- Good understanding of GAMP 5 Guide (GAMP 5) and various Regulatory requirements including CFR part 11, EU Annex 11
- Handson experience on ServiceNow (SNOW) ITOM and ITSM
- Handling of Business Application (BA) in SNOW
- Creation changes in SNOW
- Handling of Deviation in Novoglow
- Managing documents in Veeva Vault
- Handson experience TIMS as Testing Tool
- Handson experience AzureDEvOps (ADO)
- Used QMS Pileline for Automating Testing
- Undergone Agile Safe training
- ITIL V4.0 Foundation Training
- GxP awareness Training
- Systematic Trouble Shooting Training
- Provided Trainings to Product Teams on Qualification awareness session
- Providing training to product team members on Testing tools and Service Now tools
- Providing the trainings to the newly joined team members on NN tools and Process
- Worked with 11 different Product Area within the GITO
- Driving Qualification Activities with 5 different Product Area in 1 PI
- Working in 4 different Time Zones China, India, Denmark and US in one PI
- Ready to accept Challenges and Adaptably to different work culture
- Proactiveness in learning New things
- Supportive to Stakeholder and Team Members
- Participated as Offsite Committee Member
- Participated and entrolled as a member in Talent Rotation Aspiration Track
- Currently entrolled as member for ToastMaster Club and actively participating in the activities during the weekly connects
- Supporting the team as backup to deliver the products on time
Associate Manager – Investigation, Compliance, Validation & Qualification
Pfizer Health
05.2019 - Current
- Responsible for audit compliance
- Conducting audits for better compliance
- Ensure Compliance with established internal controls
- Handling of investigation through Vault QMS and GQTS
- Handling of Investigation (DMAIC system), Technical Writing of Investigation Report
- Preparation of Phase-1 and M1 investigation reports (Yellow Belt trained)
- Handling of CCF’s and CAPA Management through QMS (Quality management System)
- Preparation and Review of SOP’s, Formats, Protocols & Report compilation for Routine and Non routine Validation (Periodic Qualification’s) and Qualification (Equipment’s and CSV)
- Veeva Vault RIM Module Configuration’s
- Train the trainer for Investigation and compliance team for ILT (Instructor Lead Training’s)
- Working In Agile and IMEx team for CI project’s
- Handling of gLIM’S
Quality Control – Reviewer and Compliance
Torrent Pharma Ltd
07.2018 - 04.2019
- Responsible for audit compliance
- Conducting audits for better compliance
- Ensure Compliance with established internal controls
- Responsible for Audit Compliance and Conducting for External vendor Certification
- Handling of investigation through GQTS
- Handling of CCF’s and CAPA Management through QMS (Quality management System)
- Preparation and Review of SOP’s, Formats, Protocols & Report compilation for Routine and Non routine Validations
Jr. Manager – Microbiology
Dr. Reddy’s Laboratories
06.2013 - 06.2018
- Preparation of audit response as SME
- Preparation of Risk Assessment for Work Simplification activities
- Handling of Equipment and Instrument Qualification
- Auditing of External Laboratories for Vendor Certification
- Planning and Maintenance of overall Laboratory activities
- Microbial Limit Test as per pharmacopeia
- Microbial Identification of Isolates by using VITEK MS System
- Handling of gLIMS
- Co-ordination with CFT for routine/non-routine Environment Monitoring Program of Clean Rooms
- Method Validations of Products as per pharmacopeia
- Maintenance of media, culture and Biological Indicators stock
- Handling of Microbial test procedure (Bacterial Endotoxin Test, TOC, Microbial Limit Testing, Biological indicators certifications, Microbial Media and Cultures)
- Responsible for Audit Compliance and Conducting for External vendor Certification
- Handling of investigation through SAP
- Handling of CCF’s and CAPA Management through SAP (Quality management System)
- Training Co-ordinator for Microbiology Department
- Responsible for compliance with all cGMP and procedural training of new employees
- Assigning Scheduled and revised SOP trainings through LMS (Learning Management System) Module and maintenance of training records of Team
Executive - QC
Virchow Biotech Private Limited
Hyderabad
09.2012 - 06.2013
- Microbial Identification of Isolates by using VITEK MS System
- Co-ordination with CFT for routine/non-routine Environment Monitoring Program of Clean Rooms
- Maintenance of media, culture and Biological Indicators stock
- Handling of Microbial test procedure (Bacterial Endotoxin Test, TOC, Microbial Limit Testing, Biological indicators certifications, Microbial Media)
BCIL Trainee
Mediclone Biotech
Chennai
01.2012 - 07.2012
- Handling of Microbial test procedure (Microbial Limit Testing, Microbial Media and Cultures)
- Analysis of stability samples at real time, accelerated and intermediate temperatures
- Audit Participations: Coordination and participation in quality audits and Review of Deviations
- Participated in US FDA, TGA, Japan, Mexican, Anvisa, Health Canada Regulatory Audits, Internal Audits, Audits conducted by external agencies, Customer Audits and Regulatory Authorities
- Participated in third party external quality audits
Education
Msc - Biotechnology
Annamalai University
Tamilnadu01.2011
Bsc - biotechnology
Andhra University
01.2009
Skills
- IT compliance
- GxP compliance
- Risk assessment
- Audit management
- Qualifications strategy
- Service documentation
Disclaimer
I consider myself familiar with the above-mentioned aspects. I hereby, declare that the information furnished above is true to the best of my knowledge.
Languages
- Telugu
- English
- Tamil
Personal Information
Date of Birth: 06/29/89
Timeline
IT Validation & Compliance Specialist I
NovoNordisk
10.2022 - Current
Associate Manager – Investigation, Compliance, Validation & Qualification
Pfizer Health
05.2019 - Current
Quality Control – Reviewer and Compliance
Torrent Pharma Ltd
07.2018 - 04.2019
Jr. Manager – Microbiology
Dr. Reddy’s Laboratories
06.2013 - 06.2018
Executive - QC
Virchow Biotech Private Limited
09.2012 - 06.2013
BCIL Trainee
Mediclone Biotech
01.2012 - 07.2012
Msc - Biotechnology
Annamalai University
Bsc - biotechnology
Andhra University
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