Quality Control Assurance

NIKUNJ PATEL

*** ****** ******, *** # * Phone: 716-***-****

Jersey City, NJ 07307 E-mail: ******.****@*****.***

Objective: Seeking a challenging position in an enterprising and progressive organization which provides scope and opportunities to utilize my pharmaceutical, technical and communication skills to excel my professional career

Professional

Experience: Unique Pharmaceutical Ltd., Ankleshwar, India May 2008 to Aug 2008

(Now J.B.Chemical & Pharmaceuticals Ltd.)

QA/QC Intern in the manufacturing plant of Nifedipine Tablets

* Explored and developed sampling plan for the manufacturing process of Metrogyl (Metronidazole IV) and Nicardia (Nifedipine)

* Performed in-process and end product quality control and quality assurance tests to validate the integrity and quality of finished products

* Played an integral role in QA unit’s activities including development of SOPs, recommendations for improvement of reliability and efficiency of key analytical instruments and maintaining cost of operation

* Experienced in performing of in-process and finished products using HPLC, GC, Dissolution and bench Chemistry

* Performed “Wet Chemistry Tests” such as titration, PH, alkalinity tests etc.

* Conducted assay analysis, chemical solution preparation & chemical synthesis

Lincoln Pharmaceutical Ltd., Ahmedabad, India May 2007 to Jan 2008

Production Chemist Intern in the manufacturing plant of various solid dosage forms

* Performed dosage form proportion calculations to establish NEPIN-SR-10 Tab,(Nifedipine extended release tablets)

* Led several tests to increase the strengths Nifedipine tablets and documented results of the tests for future reference and modification

* Good experience with ICP, LC, FTIR, UV-Vis, NMR and other analytical lab instruments

* Prepared Method Validation Protocols, SOPs and Reports using Microsoft Office

* Conducted analysis of commercial, clinical and developmental samples to comply with GMP standards and guidelines

Education: New Jersey Institute of Technology, Newark, NJ Dec 2010

* Master of Science in Pharmaceutical Engineering GPA: 3.23/4.0

Ramanbhai Patel College of Pharmacy, Gujarat University, India May 2008

* Bachelor of Science in Pharmacy GPA: 3.84/4.0

Project: Validation Qualification of the Environmental Chamber Jan 2010 to May 2010

Pharmaceutical Validation term project at the New Jersey Institute of Technology

* Collected URS (User Requirement Specifications) and prepared the draft of URS for Hotpack Stability Chamber Model 417533

* Reorganized and recorded traceability matrix and protocol for installation, operational and performance qualification tests’ for the chamber

Computer Skills: Excellent knowledge of MS Office tools, MS Access, MS Project and working knowledge of Minitab

Coursework: Major Courses taken at the New Jersey Institute of Technology

Principles of pharmaceutical engineering, Validation and regulatory issues in the pharmaceutical industry, Pharmaceutical unit operations (liquid and dispersed phase systems), Solids processing, Principles of pharmacokinetics and drug delivery, Pharmaceutical facility design, Pharmaceutical packaging technology, Industrial quality control

Presentations and Projects:

* Roller Compaction Process for Roller Compactor WP 200 VN PHARMA

* Biologics packaging and reformulations

* Newer approaches to ensure quality in Pharmaceutical Industry(PAT, QbD)

Major Courses taken at the Gujarat University

Pharmaceutical chemistry, biochemistry and analytical chemistry, Pharmacokinetics, pharmaceutics and dosage form design, Microbiology, Pharmacology, clinical trial studies and human anatomy, Pharmacognosy

Practical experiments performed:

* Experiments using HPLC, HPTLC, GC, UV/VIS and TLC

* Analytical Experiments, Assay analysis, Chemical synthesis

* Instrumentation Calibration, Titration, PH Tests and Alkalinity Tests

* Dissolution tests, Disintegration tests, Hardness and Friability tests

Achievement

And other skills:

* Under my leadership as a cricket team captain throughout the Inter-College tournament, led the team to the final game and won the championship

* Served as a Group leader of Financial, Design and Technical Committee of Avalanche - a national level Pharmacy Technical Summit held at Changa, India in December 2007

Affiliation: International Society of Pharmaceutical Engineers (ISPE), Member

Registered Pharmacist of India, Member

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