Testing Quality Control
Resume:
Suchi Jagini
Lawrenceville, New Jersey - 08648
Email: ***********@*****.***
Objective: To obtain a position in a professional environment where I can
serve and advance my employer's objectives
2 Experience Summary:
. A skillful analytical chemist and task leader in validation, method
transfer, method development, stability and finished product with 8+
years experience in QC/QA in the pharmaceutical industry.
. Leads consistently in productivity, quality and teamwork metrics.
Drives continuous improvement initiatives within Quality Control.
. An experienced Chemist with comprehensive knowledge of cGMP and cGLP
regulations.
. Successfully undergone five FDA audits and other customer audits.
. Experience in training junior chemists and review of note books and
other documentation.
. Experience in handling controlled drugs and drug products.
. Experience in writing Labaratory investigation reports and event
reports
. Experience in Validations for Drug substances, Drug product and
cleaning validations.
. Skilled in UPLC, HPLC, UV, IR and Dissolution.
. Experience in testing Raw Materials, In-process, Finished Product,
Stability and Process Validation Samples.
. Proficient in writing Standard Operating Procedures, Batch
manufacturing records, Test Procedures, Method Validation Protocols
and Method Validation Reports.
. Knowledgeable in MS Office including MS Word, MS Excel, MS Access and
Power Point.
. Dependable self-starter and team player who maintains order and
assures safe work practices to complete tasks with efficiency and
effectiveness
. Dedicated and detail-oriented professional with outstanding problem
solving and time-management skills.
. Excellent Oral and written communication skills.
3 Work Experience:
Senior Analytical Chemist (September 2007 to Current)
Tris pharma Inc.
Monmouth Jct, NJ
. Experienced in UPLC and HPLC method validations on Drug Substance and
Drug product.
. Experienced in cleaning validations.
. Experienced in Process Validation and test batch release testing.
. Experienced in Raw Materials, In-Process Testing, Finished Product
Testing and Stability Testing.
. Experienced in performing assigned laboratory support duties in order
to maintain a safe and efficient laboratory.
. Experience in Labaratory Data Review.
. Experience in writing methods, Method validation protocols and Method
validation reports as required.
. Experience in Dissolution apparatus, UPLC, HPLC, UV and FTIR.
. Experience in writing and review of Laboratory note book.
. Proficient in writing Standard Operating Procedures, Test Methods,
Method Validation Protocols and Method Validation Reports.
. Responsible for revising and updating existing methods.
. Preparation of product specifications for testing and registrations.
. Experienced in Waters Millenium, Empower and Class VP(Shimadzu)
software
Formulation & Analytical Chemist (August 2003 to August 2007)
Accumed/Qpharma LLC.
Lawrenceville, NJ
. Experienced in HPLC method validations.
. Experienced in In-Process Testing, Finished Product Testing and
Stability Testing.
. Experienced in performing assigned laboratory support duties in order
to maintain a safe and efficient laboratory.
. Experience in Labaratory Data Review.
. Experience in writing methods, validation protocols and validation
reports as required.
. Calibration of QC instruments
. Experience in raw materials testing using pH testing, Titrations of
reagents, Dissolution apparatus, Karl Fisher titration, UPLC, HPLC and
UV FTIR. HPLC & dissolution testing of Solid dosage and Suspensions
using Empower 2, Millennium & Shimadzu (Class VP) software.
. Experience in Spray Pattern, Droplet size Distribution - Malvern
particle analyzer, Droplet size distribution by Anderson Cascade
Impaction for nasal formulations.
. Experience in writing Laboratory note book.
. Proficient in writing Standard Operating Procedures, Test Procedures,
Method Validation Protocols and Method Validation Reports
. Responsible for new product development and testing of Prescription
and Over the Counter medicines.
. Developed tablet and liquid formulations including Calcium antacids,
senna laxatives, fiber tablets, nasal sprays, throat sprays, infant
gas drops, teeth whitening gel and personal lubricants.
. Responsible for revising and updating existing products.
. Preparation of product specifications for testing and registrations.
. Preparation of master formula records and Maintenance of lab documents
and records.
Education: BS in Chemistry from Osmania University, Hyderabad, INDIA
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