HARDEEP SINGH MANGAT

**** ***** ******, ******: 732-***-****

Iselin, NJ, 08830 Email: rgqe9d@r.postjobfree.com

Objective:

Actively seeking a position in Validation and Regulatory Affairs, Quality Control/assurance, Manufacturing, Research, in Pharmaceutical, Biotechnology and Food Industry.

Key Competencies:

Extensive knowledge of FDA regulations – cGMP, GCP, GLP, 21 CFR 11, ISO 9000 and ICH guidelines.

Hands on experience in working with Laboratory Instruments like UV spectrophotometer, Autoclave, Disintegration, and Dissolution, apparatus.

Sharp ability to read and understanding instrument manuals and process protocols.

Hands on experience of making SOP’s, different qualifications documents (IQ, OQ, PQ).

Performed the assay, in-vitro studies of raw material, and finished product.

Responsible for large scale manufacturing, testing and maintaining the batch records.

Good knowledge the Process Validation, Cleaning Validation in Pharmaceutical Industries.

Theoretical knowledge about Polymer chemistry, Glass, Container Closure system and packaging perspectives and much more

EDUCATION:

Master of Science: Pharmaceutical Chemistry Jan 2010 – Dec 2011

New Jersey Institute of Technology – Newark GPA -3.5/4.0

Coursework:

Pharmaceutical analysis, pharmaceutical engineering, medicinal chemistry, biochemistry, organic chemistry, analytical chemistry, Pharmaceutical Facility Design, Validation and Regulatory Issues in Pharmaceutical Industry, Pharmaceutical Packaging Technology and

Academic Projects:

• Directly coupled HPLC- MS and HPLC-MS-NMR for Ibuprofen metabolites and Urine extracts.

• Isothermal Titration Colorimetry and Differential Scanning Colorimetry.

• Project on Injection Molding Process.

• Detailed study of bioreactors Design, Manufacturing and Functionality.

• Validation and Qualification of the Environmental Control Chamber.

(Prepared URS, IQ, OQ and PQ towards the qualification of an environmental chamber)

Bachelor of Pharmacy June 2004 – July 2008

Punjab Technical University, PB, INDIA GPA 3.4/4.0

Coursework:

Pharmaceutics, Pharmacology, Biochemistry, Microbiology, Biotechnology, Medicinal Chemistry, Analytical Chemistry, Pharmaceutical Management, pharmaceutical analysis, Chemistry of Natural Products, Computer Applications and Statistics.

Work Experience:

Gary Pharmaceuticals, Punjab, India Aug./2008- July/2009

Quality Control Associate

Performed routine physical tests (pH, appearance, viscosity, specific gravity) and chemical analysis (assay, impurity and preservative) of samples to support product development and stability studies.

Performed dissolution, disintegration and friability tests on tablets.

Prepared and maintained laboratory documents under the regulatory compliance.

Under supervision of seniors performed analytical method development, validation and execution.

ASBASJS College of Pharmacy, Punjab, India

Research Assistant

• Prepared a report on Taste masking as consequences of various techniques July 2007 -Dec 2007

• Preparation of the syrup and Evaluation of different parameters of the tablets Jan. - 2008- June 2008

Internship June 2006 – July 2006

Park Pharmaceuticals, Panchkula, India.

• Interned with small pharmaceutical manufacturer of Ointments, Tablets, Capsule, Syrups, (Dry and Liquid), Tonics.

• Rotated through Tablet Formulation, capsule, ointments as well as Syrup Preparation.

Laboratory Skills – Chromatography, GC, UV Spectroscopy, Colorimetry, Flame Photometry, Calibration of Instruments.

Computer Skills:

WINDOWS 95/98/00/XP/VISTA/7, Macintosh, MS Excel, MSWord, MS PowerPoint, MS Project, MS Access, Adobe Photoshop

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