ABIR MUKHERJEE

Implementation of enterprise application to various site of Aurobindo.

Handling of change controls ,deviation as and when required.

Ensuring timely delivery of Computer system validation deliverables.

Ensuring IT compliances to all enterprise and laboratory computerized systems.

Performing periodic review for all GxP applications, on timely manner.

Ensuring back up of each an every application as per the given frequency.

Restoration verification of backed up data in defined interval.

Project handled-

Implementation of electronic batch record (MES) to various site of Aurobindo.

Implementation of Electronic log , preventive maintenance management system , House keeping management systems , Calibration management system.

Implementation of Cloud based application like Caliber LMS , HRMS to various site of Aurobindo and its subsidiaries.

• Ensuring timely delivery of CSV, IT projects
• Overall QA-IT compliance
• Quality Management System
• Leading QMS site team
• Ensuring proper investigation of QNs on time
• Trending of quality notification
• Presenting monthly QRM
• Statistical evaluation and analysing of root causes
• CAPA review and Effectiveness check
• Achievement
• Build an in house CSV team to avoid third part validation expenditure
• Where in an Empower3 projects able to save above 50 lakhs by performing application validation in-house.

• Responsible for implementation of enterprise application (QMS,LIMS ,PMTS,CMS ,e-BMR etc.)to all active sites
• Implementation of Caliber LIMS, DMS, TRIMS, EPIQ
• Leading CSVC team to ensure execution of proper testing plans and validation deliverables released as per projects timeline
• Responsible for maintain IT compliance and audit readiness by closely working with site QA team
• Co coordinating with cross- functional teams for ensuring successful implementation of applications
• Coordinating with vendors for pre and post implementation supports
• Handling QMS documents as and when required
• Implementation of electronic batch record (Manufacturing execution system ) at plant
• Periodic audit trail review
• Address if any discrepancy found
• Ensure compliance to 21 CFR part 11, EU Annex 11, GAMP5
• Electronic record and electronic signature
• Projects handled- Manufacturing system automation and digitization projects.

• Corporate quality and compliance., Independently handled all CSV responsibilities of mankind research centre as compliance team member while closely collaborating with DQA
• PROJECT HANDLED
• Computer system validation: CSV of Laboratory computerized system- Lead project team, execution planning, and Ensuring 21CFR part 11 compliance for computerized systems
• Worked closely with DQA in assisting CSV green field project at Mankind research centre
• Implementation DMS & Track wise: Active project participant in implementation of Document management system (D2 LSQM) and Track wise (QMS Module)
• Design of business requirement specification, Software testing in consultation with third party vendor
• Paperless operation: Encouraging paperless workflow by implementing e-sign and e -documentation for computerized systems
• Achievement
• Successfully refunctioned the developmental laboratory within twenty days after major server disaster, able to save approx
• 1 crore rupees of the company by validating all the instrument without any external third party support.

• Quality Assurance
• Responsible for QMS and Computerized system validation
• Worked in IPQA as shop floor QA.

• Worked in QC department as Reviewer of analytical documents
• Other responsibility – Maintaining Laboratory
• Compliance and OOS , Incident handling.

• Other responsibility – To Release FP after analysis
• Maintaining laboratory compliance
• Participated in laboratory computerised system validation as application tester.

• Analysing raw materials ,Finished products, stability studies
• Maintaining laboratory compliances
• Worked laboratory non routine section – Calibration of HPLC, UV, Balance others laboratory instruments.

• Worked in QC as an analyst- Analysing raw materials, Raw material Sampling
• Laboratory compliances.