Pratibha Batra

• Designing experiments to address market complaints and regulatory queries.
• Approached regulatory queries regarding method validation and harmonized the criterion across products as part of ,Life cycle management of analytical procedures.
• Scheduling and compilation of bridging method validation studies done as part of regulatory queries.
• Site Investigation Team member, for Audit readiness
• Qualified reviewer of analytical data.
• Performed Method Validation protocols & reports preparation for Analytical assays.
• Efficient handling of QMS,Change control, and Phase 1b Investigation.
• SUCCEED team member for OOT & OOS Global procedure harmonization.
• Annual & Quarterly Product Quality Review report preparation
• Continuous Method Improvement of Analytical methods through exploratory studies.
• Established Lean Daily Management concept as the board owner
• Laboratory Information Management-Core team member & Troubleshooter

Implementing LIMS in QC and ASAT laboratories.

Analyst support w.r.t LIMS troubleshooting.

Preparation and execution of test scripts for validation.

Process flow chart creator w.r.t laboratory processes and LIMS software master data creation.

Master data creation of Product,Analysis and Batch Workflow.

Empower connectivity establishment with LIMS.

Representation of Custom fields-Empower software in LIMS.

Internship @ Strategy Portfolio Planning Management

• Internal Gig, Assessment of Business model for Cell and Gene therapy Scope in Biologics
• CGTs Therapeutics area delved into & researched on Manufacturing of CGTs
• Developed business, financial and analytical skills needed for career

• Laboratory Information Management (LIMS) Phase 1 & 2: Core team,Troubleshooter & Laboratory support Group Trainer for Custom Fields Implementation and LIMS CDS Interface in Empower 3.
• Efficient handling of QMS ,Change control and Phase 1b Investigation.
• Preparation/Revision of Standard Testing/Operating Procedures,Assessed PvP of STPs.

• Qualified reviewer of cGMP documents.
• Laboratory Information Management (LIMS) Core team OQ&PQ of Custom fields Custom Fields Implementation in Empower 3 Implementation of LIMS CDS Interface for Empower 3
• Performed formula verification in LIMS
• SUCCEED representative of Capability Building team and PvP assessment participant.
• Efficient handling of Quality management systems Preparation/revision of Standard Operating/testing procedures.

Custom fields creation in Empower for automated calculations.

Connectivity development for custom fields of Empower software and their representation in LIMS.

• Lead Investigator of Lab investigation records increased Right First Time
• Handled campaigns support from QC as SPOC for one MAb. Validation studies for MAbs.
• Preparation/revision of Standard Operating /Testing procedures.
• Execution of relevant Protocols and Planning documents

• Qualified & executed analytical assays alongwith excipient analysis for lot release & stability samples efficiently
• Horizontal team representative for MAb.
• Revision of Standard Testing/Operating Procedures & ROAs/DS Tech transfer of assays - R&D to QC.
• Deviations/OOS/Atypical/Aberrant results management.
• Addressing market compliance queries.

• Qualification in assays for MAbs and complex proteins involving SE ,IEX,RP HPLC, & Calibration of the Waters HPLC instruments.
• Working in cGMP lab,Lot release& Stability samples analysis.
• Internal and external audit readiness.