Quality Control Managerwith7+years experience in qualitycontrol and quality assurance. Lead the Quality Control activities to ensure timely testing and release of all samples. Lead the design and execution of validation projects. Serve as the subject matter expert on specific areas and techniques. Review and audit test results. Oversee the laboratory for GMP and Safety complaince.Hands on experience of analytical instruments or techniques including HPLC, UPLC, TLC, UV-Vis & IR spectroscopy, Karl-Fischer, Dissolution Tester, Malvern Particle Size analyzer, etc.
*Performed Analytical Method Validation, Cleaning Validation and Analytical Method Transfer.
*Performed product process validation and instrument qualifications (IQ, OQ and PQ protocols and reports).
*Knowledge of cGMP, US FDA regulations (21 CFR, part 210, 211) and ICH- guidelines.
*Performing routine and standardized tests procedures and examinations of the product.
*Experience of WATERS EMPOWER and SHIMADZU\'S CLASS-VP Softwares.
*Knowledge of wet chemistry and process development.
*Good communication and human relations skills. Managerwith 7+ years experience in quality control and quality assurance.
High-Performance Liquid Chromatography
EMPOWER 3 Software
IR, UV Spectroscopy
Particle Size Distribution
Solid Oral Dosages
Analytical Method Validation
MS Office proficiency
Handled FDA/DEA Audits
STPs, SOPs, Protocols and Report writing.
Quick learner, good oral and written communication, problem solving ability, able to work in team or independently, able to lead team, able to work long hours and ability to interact with upper management and act as a liaison between upper management and lab staff.
Quality Control Manager, 01/2015
to Current Leading Pharma – Fairfield,
Reviewing Batch record, STM, SOPs, stability testing data and auditing laboratory note books and instrument calibration records.
Provide comprehensive formal and informal leadership to promote work environment and communicate overall business expectations to QC.
Supervise chemists to include, but not limited to overseeing testing, check progress of samples for release and ensure assigned tasks are performed on timely manner.
Work distribution among chemists based on priorities.
interact with other departments for testing information required for methods and or proper documentations.
Maintaining an orderly laboratory environment.
Monitoring stocks of reagents and laboratory supplies.
Train new employees on basic laboratory techniques.
Ensures communication flow in team and support to peers and managers.
Recommended and executed quality improvements for production and product quality.
Senior Quality Control Analyst, 08/2007
to 01/2015 Excellium Pharmaceuticals – Fairfield,
Analytical testing of Finished Product and Stability sample.
Test include ID, Assay, Content Uniformity, Dissolution, Impurity, Water content using instruments like FT-IR, HPLC, UPLC, Dissolution Tester, UV Spectrophotometer Karl Fischer titration , Orion pH meter, etc.
Perform Raw material (API/Excipient) Testing which include ID, Assay, Impurity, LOD, Heavy metals, Moisture Determination, residual solvent and particle size analysis.
Perform In-Process testing for blend uniformity and physical testing of blend include Bulk/Tapped Density and sieve analysis.
Perform sampling and testing of Packaging Components like bottles, caps, labels, inserts, rayon coil, etc.
Maintain, calibrate and troubleshoot of equipment like shimadzu HPLC with Class-VP software, Waters HPLC with Empower Software, Acquity UPLC with Empower Software, Karl-Fischer Titrator, and Varians Dissolution Tester.
Prepare analytical solutions, TS/VS, mobile phase, diluents, washing solvents, and dissolution media.
Maintain laboratory records and log books in accordance to cGMP requirements.
Perform temperature, Humidity and negative pressure check of each manufacturing and packaging rooms, record and maintain logbooks.
Helping quality assurance with start-up and in-process testing of Solid Oral Dosages.
Works independently on analytical projects.
Responsible for assuring adherence to Federal (FDA, DEA, EPA) and OSHA regulations, cGMP\'s, SOP\'s, company policies and procedures.
Can use calipers, micrometers, measuring tapes, and misc automated machines to perform testing.
Lab Technician, 08/2006
to 08/2007 Delta Circuits – Fairfield,
Performing a wide range of chemical analysis for all types of chemicals used for Circuit Board Manufacturing process, utilizing spectroscopy, spectrophotometry, potentiometry and wet analysis techniques.
Prepare test solutions, compounds and reagents for use in laboratory to conduct a test.
Compile and analyze test information to determine process or equipment operating efficiency and to diagnose malfunctions.
Record, Organize and report test data to Production Manager and Quality Manager.
Maintain and calibrate lab equipments like UV, AA spectra, Orion pH meter, balances and scales, hull-cell tester, peel strength tester, Omega conductivity tester, XRF machines, etc.
Verify in-house standards against NIST traceable standards which include digital timers and stop watches, calipers and micrometers, Multi-meters and weights.
Assisted in set up and operation of waste water system and RO water system.
Assisted in set up and operation of automatic electroless and electrolytic copper plating, immersion silver process, developing, etching and stripping processes.
Prepared various reports and records, from using the information I entered into the computer system.
Master of Science: Organic Chemistry,
May 2006 School of Science, Gujarat University - Ahmadabad,
Bachelor of Science: Chemistry,
April 2004 R.K. Parikh Arts & Science College, Gujarat University - Petlad Chemistry