Quality Control Management
Resume:
Kartik Patel
Email: ***********@*****.***
SUMMARY
A Highly accomplished individual with hands on experience in analytical techniques such as HPLC, GC, UV Spectrophotometer seeking for a job as a Quality control chemist or an analytical chemist or a research and development position in pharmaceutical or biotechnological industry. An individual holds on extensive skills in equipment validation, cleaning validation, process validation, computer system/automation system validation, regulatory affairs. An individual having a good skill of writing SOPs Protocols and User Requirements Specification as per FDA guidelines, GMP and GLP,21CFR.
SKILLS
• Expertise in testing of raw materials and finished products by HPLC, FT-IR and Titration Assays with the different approaches of method development techniques under GMP and GLP compliance.
• Proficiency in interpreting and documenting graphical results using Empower, Spectrum and LIMS as per FDA guidelines.
• Understanding of GC, Ion chromatography, UV and IR Spectrophotometer, Mass Spectrometer, Electro chromatography, Karl Fischer.
• Command on basic chemical and analytical skills such as pipetting, TLC, titration, pH-meter, Polari meter, Colorimeter, Conductometer, analytical balance, Sterilizer, Autoclave, Incubator, ELISA and Electron Microscope.
• Expertise in solving visual defects during tablet manufacturing such as capping, cracking, sticking etc.
• Hands on experience with dissolution-disintegration-centrifugation apparatus, Tablet-Press and Capsule-Press for analysis of solid dosage form.
• Knowledge in documenting test results as per FDA guidelines, cGMP, GLP, GCP and Laboratory Information Management System (LIMS), ISO 9000, ICH Q7 and 21CFR part 11,110,210,211.
• Expertise in validation of pharmaceutical equipments.
• Knowledge of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of an Environment Chamber.
• Qualification and calibration of lab scale equipments.
• Knowledge of writing SOPs, Protocols and User Requirements Specification.
• Holds on an extensive skill in Computer Operating System such as Windows XP/Vista, MAC OX and some applications such as Microsoft Access, Minitab, and Office 2010/2007/2003.
EXPERIENCE
New Jersey Institute of technology Jan 2011 - April 2012
Research Assistant
Pharmaceutical chemistry department (Organic chemistry Lab.)
Pharmaceutical engineering department (Pharmaceutical Technology Lab.)
ALEMBIC PHARMACEUTICALS (P) LTD, Vadodara, India Nov 2009 – Aug 2010
R&D Analytical Chemist:
• Qualitative and Quantitative analysis of raw materials, in-process products and finished products using HPLC, FTIR, UV-VIS spectroscopy, Titration assay.
• Performed rigorous quality control checks on in-process tablets such as stability, content uniformity, weight variation, dissolution, disintegration, hardness in accordance with USP.
• Performed wet chemistry using Titration, pH-meter, viscometer.
• Solving visual defects during tablet manufacturing such as capping, cracking, sticking by adding suitable raw materials or adjust the weight of different materials in given product formula.
• Documented all quality reports and supporting data related raw materials, finished products and packaging goods as per FDA regulations, cGMP and GLP.
Shine Pharmaceutical Pvt LTD, Vadodara, India April 2009 – Sep 2009
QC Chemist:
• Responsible for Sampling, Testing and Release or rejection of raw materials as per specified method.
• Thin Layer Chromatography, Gas Chromatography, UV-analysis, KF, HPLC, IR, wet chemistry, TOC, LOD, pH analysis.
• Maintained testing records as per standard procedures for raw materials.
• Performed analytical method validation and Calibration of laboratory instruments.
• Controlled the sample store room and Performed stability study.
• Prepared standard volumetric solutions and maintained standardization record.
• Maintained Labeling procedure at all the stages and document all lab work.
• Analyzed complaint samples as and when required (Retesting of raw material).
• Followed SOP and cGMP regulations when testing raw material.
Cadila PHARMACEUTICAL LTD, Gujarat, India May 2008 – Aug 2008
Intern: Formulation & Production Department
• Performed tablet manufacturing by wet and dry granulation methods using tablet press in cGMP environment under supervision.
• Sampling of raw materials and finished products and release it after testing to use it for tablet manufacturing.
• Prepared, reviewed and analyzed the analytical reports of raw materials and finish products.
• Prepared Master Manufacturing Records and Batch Manufacturing Records to support all audit activities as per FDA guidelines and cGMP.
• Controlled and documented all inventory of raw materials, finished products and packaging goods.
Deep Pest Management, Gujarat, India Sep 2006 – Jan 2008
Project coordinator & Field supervisor
• Performed Quality testing services with central pollution control board (Govt. of India).
• Management and pollution testing & documented in Pharmaceutical, Bio-tech and chemical industries.
• Basically worked under different pollution control agencies for Govt. of India.
EDUCATION:
New Jersey Institute of Technology Newark, NJ (GPA: 3.2) May 12
MS Pharmaceutical Chemistry
New Jersey Institute of Technology Newark, NJ (GPA: 3.3) Aug 11
Certificate Pharmaceutical Technology
Indira Gandhi National Open University, INDIA (GPA: 3.3) Aug 10
P.G Diploma Healthcare management
Gujarat University, Parul Institute of Pharmacy, INDIA (GPA: 3.6) May 10
BS Pharmaceutical science
Related Course Work:
ACADEMIC PROJECTS
• Preparation of nanovehicles for targeted drug delivery
Application of nanotechnology in pharmaceutical research has opened new frontiers for drug development and its efficient delivery
• Pulsing Method in Wet Granulation:
By decreasing the drying process time even at high relative humidity controlling the granule size.
• Quality Management System:
It provides a path to the continuous improvement of the process as per cGMP compliance.
It reduces the product recall and reworks defects which in turn help to reduce the cost as well as increases the customer’s satisfaction.
PRESENTATIONS
• Presented thesis on “Research and Development: Novel Drug Delivery Systems (NDDS)”.
• Delivered a project on “Therapeutic Drug Monitoring” in “A National Seminar on Clinical Research” jointly held by Parul College of Pharmacy and Alembic Pharmaceuticals.
• Delivered a Case presentation on various diseases like Obesity, Angina Pectoris, Hypertension, Congestive Cardiac Failure (CCF), Asthma, Peptic Ulcer, Tuberculosis (TB), Anemia and Rheumatoid arthritis.
LEADERSHIP
• Lead a team of national seminar on Clinical Research jointly organized by Parul College of Pharmacy and Alembic Pharmaceuticals.
• Lead a project based on “Therapeutic Drug Monitoring”.
PERSONAL INFORMATION
Work Status: EAD (based on green card) * NO Sponsorship required.
Location Preference: OPEN TO RELOCATE
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