Inde Virbhadra Virpakshappa

I am thankful and pleased to introduce myself Mr.Virbhadra Virpakshappa Inde currently working as Deputy Manager CQA in Biocon limited,from AUG. 2023 to till date with 11+ years of experience in IT -Quality Assurance,CSV ,Quality Assurance.

Currently am responsible for CSV,and ITQA activities with e-compliance and handling QMS Managements of Corporate Applications and computerized systems of manufacturing equipments which are applicable for Formulation and API sites of Biocon for applications such as Trackwise,DMS,LIMS,SAP-ATTP,vLMS,SAP-SF etc.

• To work,learn and grow with an organization to reach a high level in managerial hierarchy and be instrumental in driving it beyond its mission by adhering to its values and utilizing my potential and talents to its fullest.

• To ensure that software/application\equipment being implemented as part of Digitization Projects are validated/qualified as per current SOP and regulatory guidelines Such as 21 CFR Part 11,GAMP-5,EU-Annexure 11 for Computerized System Validation before release for production use.
• Handling of CSV Projects as a Project Manager and actively involved in Review and Approve CSV deliverables like User Requirement Specifications, Risk Assessment, GXP Assessment, Vendor Evaluation Questionnaire, Validation Plan, Qualification documents, Functional Specifications, Configuration Specifications, Requirement Traceability Matrix, Electronic Records Electronic Signatures Compliance Assessment, Data Integrity Verification Checklist etc..
• Assessment Risk Assesment, risk analysis and mitigation action completion and monitoring of implemented actions.
• Expert in V-Model CSV Validations with handled knowledge on agile methdology.
• Handling defect management,investigation and closures identified during CSV Validations.
• Prepare the project tracker and manage the project day and day out activities with updating status of projects with the communication with CFTs and vendors.
• Handling of QMS activities such as Deviation, CAPA and closure of CAPA within the timelines and CSV life cycle documents for the corporate systems such as Trackwise,DMS,LIMS,SAP-SF,vLMS,SAP-ATTP etc...
• To review and approve Corporate SOPs and cross functional SOPs as part of continual improvement and simplification where applicable.
• Responsible for ITQA Responsibilities Such as Review of qualification documents with respect to IT software’s And Manufacturing, Packing Equipments Systems such as Trackwise,DMS,SAP-ATTP,SAP-SF,vLMS, Valgenesis(VMS) systems.
• Actively involved in SDLC life cycle and computer system validation by using Agile, V-Model Validation Stratagey.
• Ensuring of 21 CFR Part 11,cGMP Annex 11 compliance for all Manfacturing equipment’s, systems.
• Actively Participates in Audits And Inspections, including compliance to finding gaps and observations with monitoring of CAPA actions.
• Review of Monthly Audit trail for Trackwise,DMS Corporate Systems.
• Handling of SAP,DOCHUB,LIMS SYSTEMS for Quality Assurance.
• Involved in CAPA management,CAPA tracking in ICMS System.
• Preparation review and approval of SOPs related to Quality Assurance,Manufacturing,packaging systems.
• Performing self inspection on monthly basis,preparation of observation reports and review and approval ofcompliance for self inspection.

Name                       : Inde Virbhadra Virpakshappa

Date of Birth            : 15/07/1989

Father’s name          : Inde Virpakshappa Virbhadrappa

Gender                     : Male

Marital Status          : Married

Languages Known    : English, Hindi, Marathi and Kannada.

Permanent Address: Inde Virbhadra Virpakshappa near Apang School Sastur,

Post: Sastur, Tq: Lohara, Dist: Osmanabad Pin•413606

1.Mr.Dhananjay S Alange

(Site QA Head) Zydus Life Sciences-Corporate.

2.Dr.C.M.Jangme

(Principal) D.Y.Patil College of Pharmacy-Kolhapur.