Ilaxi Purohit
Hillsborough,USA
Summary
Dynamic Scientist with extensive experience at Thermofisher Scientific, excelling in HPLC and OOS investigations. Proven ability to lead teams and enhance quality through effective SOP modifications and CAPA implementation. Recognized for analytical thinking and problem-solving skills, ensuring compliance with cGMP standards while managing multiple projects efficiently.
Overview
17
17
years of professional experience
Work History
Scientist- II
Thermofisher Scientific
05.2022 - Current
- Scheduling daily QC activities in the lab, including, but not limited to the testing and release of all incoming samples in the lab within the time to support operation.
- Assisting all QC lab personnel to complete their assigned task within their given time.
- Reviewing all documented test results in details, in AR continuation sheets and in lab notebooks and releases the products in database – Sapphire.
- Performing OEM inspections, review and released them within given turnaround time.
- Ensuring all testing performed in the lab follows current test methods, SOPs and cGLP/cGMP standards.
- Performing biological testing of the products by Gel Electrophoresis technique to analyze DNase, RNase, and Protease.
- Having detailed operational knowledge of laboratory instruments like HPLC, GC, UV, Karl Fischer, etc. and troubleshooting them whenever it’s required.
- Managing laboratory instruments by performing internal instrument verification routinely before lab starts working in the morning and also periodically.
- Scheduling PM and calibration of lab instruments.
- Participated in the internal and external audits, audit follow-up meetings and implemented any process or documentation accordingly.
- Performing QC department and interdepartmental GEMBA walk periodically and communicate with team for safety and hazardous issues and report them to management.
- Leading the Out of Specification investigation (OOS), supporting QA and operation to improve and maintain quality of the product.
- Working with QC lab supervisor and QA to file any quality deviation and CAPA.
- Assisting QC lab supervisor to creat new SOP and modifying existing SOPs
- Assisting QC supervisor to update KPI metrics,
- Attending leadership meetings to ensure continuous lab support to the operation.
- Ability to handle multiple projects and working on them independently and simultaneously.
- Trained newly joined employees for all their assigned job duties.
- Managing QC lab team training records and if required assigned retraining of employee.
- .Working with analytical development team for testing method modification and updates.
- Completing all assigned tasks and assisting team to complete their day-to-day laboratory operations within the given time.
- Demonstrated strong written and verbal communication skills in team interactions.
- Updated and maintained laboratory supplies to ensure availability for testing.
QC Chemist
Akorn Pharma
Somerset, USA
11.2021 - 05.2022
- Perform analytical testing of all incoming in process, finished products.
- Prepare and conduct product stability testing.
- Document and update lab books and analytical test data sheet daily for supervisor to review.
- Daily calibration of Laboratory instruments.
- Filing OOS and assist team for their investigation.
- Work in accordance with approved methods, SOPs.
QC Chemist
Shiseido America
East Windsor, USA
05.2017 - 11.2021
- Perform analytical testing of all incoming Bulk and finished skincare and cosmetic products by using HPLC, GC and other common analytical laboratory techniques.
- Prepare and conduct product stability testing and troubleshoot issues.
- Releasing test results of products within time intervals using system LIMS.
- Updating logbooks with detailed testing information and support archiving the records.
- Performs testing for the qualification of laboratory reference standards.
- Modify, improve and transfer analytical testing methods in CompliantPro system.
- Troubleshooting, maintenance and scheduling calibration of Laboratory instruments.
- Leading the group to manage daily tasks in the lab to ensure work queue is managed and providing technical advice to team members.
- File change control, deviation and investigation of OOS.
- Work in accordance with approved methods, SOPs, cGMP and cGLPs.
- Participate routinely in performing internal QC audit.
- Train newly joined employees to perform their routine tasks independently.
- Generate Purchase Orders for the laboratory requirements using Mapix system.
- Support Continuous Improvement activity by reviewing product performance and testing data including change control and risk assessment.
- Print and maintain batch records and QC logbooks with manufacturing team.
- Review and preparation of new SOPs and modifying existing SOPs to comply with QA requirements.
- Actively participate in the document reviewing room during regulatory audits.
Analytical Chemist– QC
Vita Pure Inc.
New Jersey, USA
03.2014 - 04.2017
- Sampling of all incoming Raw Materials and Finished products.
- Testing of all incoming Raw Materials and finished products by using FTIR, HPLC, TLC, pH meter, Moisture Analyzer, Melting Point, Bulk density, tapped density, minimum fill, Osmolality, clarity, specific gravity, etc.
- Performing Disintegration time, Friability, checking Hardness and Thickness for all tablets and capsules finished products.
- Releasing and Rejecting of all tested products within time interval.
- Perform calibration of pH meter, HPLC, IR, DT machine, Melting Point Apparatus.
- Calibration of Laboratory Glass wares.
- Updating of laboratory logbooks.
- Preparation of new SOPs and update old SOPs.
- Issuing and maintaining Batch production records according to the batch size.
- Reviewing Batch production records and compiles all data and approve batch before release.
- Issuing, reviewing and managing all Change control and deviation records.
- Participated in OOS investigation and in CAPA.
- Managing Annual product Quality records (APQR).
- Successfully work with affiliated labs and third-party agencies.
- Participated in conducting cGMP internal audit to entire Quality, manufacturing, packaging department to ensure cGMP guidelines follow properly.
Quality Assurance Officer
Farmson Analgesics
05.2012 - 12.2012
- Issuance of Batch Manufacturing records and other Quality controlled documents.
- Compiling all batch records and release manufacturing Batch.
- Maintaining Master production records and Master controlled documents and assisting supervisor to update them.
- Updating and maintain of APQR, SOPs, certificate of Analysis.
- Performing internal audit of an organization.
- Managing Change control and deviation records of manufacturing organization.
Pharmaceutical Quality Control Associate
Elysium Pharmaceuticals
06.2009 - 05.2012
- Sampling and testing of incoming Raw materials used in Prescribed drugs in accordance with IP, BP, USP & In House Specifications by using TLC, Ultra Violet (UV) Spectrophotometer, Karl-Fisher, pH meter, Polarimeter, Refractometer, Disintegration (DT) Machine, Bulk Density Apparatus, Brookfield Viscometer, Melting point Apparatus, Loss on Drying (LOD), Loss on Ignition (LOI) etc.
- Documentation, Interpretation & Reporting results within scheduled time interval.
- Perform Instrument Calibration for Karl-Fisher, Polarimeter, pH meter etc.
- Perform manufacturing Water analysis (as per IP, BP, USP & In House specification).
- Preparation of Volumetric Solutions and standardizes them.
- Assist to prepare Raw Material Specifications and Laboratory SOPs.
- ERP reporting.
Education
Master of Science - Biochemistry
SP University
06-2009
Bachelor of Science - Biochemistry
SP University
06-2007
Skills
- HPLC
- GC
- UV Spectrometer
- FTIR
- Karl-Fisher
- Polarimeter
- Viscometer
- Osmometer
- PH meter
- LabSolutions
- ClassVP
- Chromeleon
- MS office suite
- Mapix
- Compliancewire
- CompliantPro software system
- LIMS
- Agile System
- Viva
- Trackwise
- Document management system
- SOP
- Modification of analytical test method
- Change control
- Deviation
- OOS investigation
- CAPA
- APQR
- Analytical thinker
- Problem-solving skills
- Pharmacopoeia (USP, BP, EP, IP)
- Cross functional department
- QA
- R&D
- Production
- High paced environment
- Minimum supervision
- Managing team
Phone
cell, 201-238-1184
Timeline
Scientist- II
Thermofisher Scientific
05.2022 - Current
QC Chemist
Akorn Pharma
11.2021 - 05.2022
QC Chemist
Shiseido America
05.2017 - 11.2021
Analytical Chemist– QC
Vita Pure Inc.
03.2014 - 04.2017
Quality Assurance Officer
Farmson Analgesics
05.2012 - 12.2012
Pharmaceutical Quality Control Associate
Elysium Pharmaceuticals
06.2009 - 05.2012
Master of Science - Biochemistry
SP University
Bachelor of Science - Biochemistry
SP University