Kandarp Patel
New Hill,NC
Summary
Dynamic QC Scientist with extensive experience at Pfizer, adept in HPLC and troubleshooting complex scientific challenges. Proven track record in training teams and adhering to strict GMP protocols. Recognized for delivering high-quality results while fostering collaboration and adaptability in fast-paced environments. Committed to continuous improvement and excellence in analytical methodologies.
Overview
13
13
years of professional experience
Work History
QC Scientist
Pfizer
03.2023 - Current
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Followed strict safety protocols, protecting staff and assets while carrying out technical procedures.
- Worked flexible hours across night, weekend, and holiday shifts.
- Worked well in a team setting, providing support and guidance.
- Learned and adapted quickly to new technology and software applications.
- Identified issues, analyzed information and provided solutions to problems.
Analytical Scientist III
Lannett Pharmaceuticals
05.2021 - 02.2023
- Method Transfer of assay, impurity methods using HPLC.
- Experienced in Analysis of drug products on HPLC, UPLC, and GC for
- assay, Impurity, dissolution, content uniformity, blend Uniformity, and residual solvent.
- Trained junior scientists specially on instrument and procedure.
- Participate in method development of dissolution and assay using existing client method.
- Working in accordance with GMP requirement.
- Prepared documents such as; SOP, COA, analytical method, Pharmaceutical sample report, method validation protocol and method validation report using Master Control.
- Expertise in analyzing finished products, process validation Samples and stability samples
- Knowledgeable in cGMP (21 CFR, 210/211)
- Review laboratory notebooks and data as per good documentation and GMP guidelines.
Analytical Scientist
Sigma pharm Laboratories
08.2018 - 05.2021
- Analysis by HPLC such as Assay, Content Uniformity, Organic Impurities, Blend Uniformity & Dissolution.
- Residual Solvents test by Gas Chromatography
- Performed type 1, type 2 and type 3 dissolution by HPLC, UPLC and U.V
- Method development and Method validation for API and finished product method for Assay, Dissolution.
- Cleaning Verification Swab collection from cGMP area as well as analysis through HPLC
- Experience on raw material tests such as LOD, Heavy metals, Sieve analysis, Particle size, ROI, Bulk and tap density, Assay by titration, Disintegration test.
- Water content analysis by using Karl Fischer.
- Performed day-to-day analysis by using HPLC, FTIR and UV spectrophotometer
- Balance and PH meter calibration.
- Prepared reports of analytical data and developing methods.
- Responsible for outsourcing samples for analysis.
- Updated stability spreadsheets into system.
- Trouble shooting for HPLC.
- Documentation and compilation of Certificate of Analysis
Assistant Store manager/ Pharmacy Tech
V care Pharmacy
01.2017 - 06.2018
- Accurately entered new patient profiles and prescriptions into medication input software system.
- Familiar with Pharmacy Insurance claim system.
- Communicated with doctor's offices via telephone, fax, and email.
- Provided friendly customer service at prescription drop-off and pick-up.
- Worked closely with pharmacists and used medication input software to safely and accurately dispense medication
Pharmacy Tech
CVS Pharmacy
04.2016 - 12.2016
- Retrieved prescription orders; accurately counted, poured, and measured tablets and medications.
- Maintained proper pharmacy and general safety procedures and standards, including department cleanliness.
- Directed operations to increase efficiency and minimize patient wait times.
Manufacturing Supervisor
Mediwin Pharmaceuticals
02.2015 - 01.2016
- Planned, schedule and coordinated detailed phase of batch production in cGMP.
- Supervised Manufacturing process involved Granulation, compression and coating
- Maintain Batch manufacturing record, inventory logbook and batch packing record according to GMP.
- Communicate with team to increase productivity.
Manufacturing Officer
Claris-Otsuka Life Sciences
03.2013 - 02.2015
- Supervised production schedules, production quality and on time delivery in cGMP.
- Assign CIP/SIP (Clean in process and Steam in process) to team members.
- Coordinated preventative maintenance on existing and new production equipment, including routine calibration. Analyzed dispensing of raw materials with GMP.
- Filling & verification of bottles [Rommelag (Blow-Fill-Seal Machine)
- Document- Batch Manufacturing Record,reporting online (SAP)
- Maintained and enforced a cleanroom working environment at all times.
Production Chemist
West Coast Pharmaceuticals
01.2012 - 02.2013
- Completed key projects on time, on budget and with a high level of accuracy in cGMP.
- Mastered the intricacies of the process flow within each department.
- Monitored and adjusted production processes or equipment for quality and productivity.
Education
Master of Science - Quality Assurance And Regulatory Affairs
Temple University
Philadelphia, PA12-2027
Bachelor of Science - Pharmacy
Rajiv Ghandhi University of Health And Sciences
Bangalore, India.08-2011
Skills
- HPLC
- GC
- UV 1800
- spectramax
- Cleaning Verification
- gLIMS, LIMS
- empower
- ASTRA
- Dissolution (USP 1,2,3)
- KF
- Disintegration, Friability, pH calibration, Moisture Analyzer
- USP/NF, EP, BP IP
- Formulation
- in-process, STAT testing
- Stability Studies
Timeline
QC Scientist
Pfizer
03.2023 - Current
Analytical Scientist III
Lannett Pharmaceuticals
05.2021 - 02.2023
Analytical Scientist
Sigma pharm Laboratories
08.2018 - 05.2021
Assistant Store manager/ Pharmacy Tech
V care Pharmacy
01.2017 - 06.2018
Pharmacy Tech
CVS Pharmacy
04.2016 - 12.2016
Manufacturing Supervisor
Mediwin Pharmaceuticals
02.2015 - 01.2016
Manufacturing Officer
Claris-Otsuka Life Sciences
03.2013 - 02.2015
Production Chemist
West Coast Pharmaceuticals
01.2012 - 02.2013
Master of Science - Quality Assurance And Regulatory Affairs
Temple University
Bachelor of Science - Pharmacy
Rajiv Ghandhi University of Health And Sciences
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