NILESHKUMAR KOTADIYA

****, **** ******* ******, *** 20 F

Anaheim, CA 92801

E mail: abg6h3@r.postjobfree.com

Cell Phone: 714-***-****

OBJECTIVE:

To be associated with your progressive organization that enhances my commitment to apply my knowledge, analytical

and instrumentation skills in the area of chemical analysis.

SUMMARY:

• Highly detailed professional with 3 years of experience as an Analytical Chemist in analysis of raw

material, intermediate and finished products.

• Performed method development, troubleshooting and Validation for HPLC, GC/MS and LC/MS.

• Experience of working under current Good Manufacturing Practice and GLP environment.

• Expert in Data Interpretation and operating HPLC, LC/MS, GC, GC/MS, UV and FT IR.

• Computer skills including MS office (word, Excel, PowerPoint), Windows XP/Vista/7 and the internet.

• Good analytical and communication skills, can work under pressure, quick learner and team player .

• Able to work in a team as well as individually and proven ability to organize and prioritize.

EDUCATION:

M.S. in Pharmaceutical Manufacturing, May 2009, GPA 3.39

Stevens Institute of Technology, Hoboken, New Jersey

Major Courses : GMP in Pharmaceutical Facilities Design, Validation and Regulatory Affairs, Chemical Process

Technologies in API Manufacturing, Bio Process Technologies in API Manufacturing, Pharmaceutical Finishing and

Packaging, Design and management of Sterile Manufacturing Facility, Engineering Economics and Cost Analysis,

Project Management.

Bachelor of Pharmacy, March 2006, GPA 3.69

Rajiv Gandhi University of Health Science, Karnataka, India

Major Courses: Pharmaceutical Analysis, Organic and Inorganic Chemistry, Bio chemistry, Microbiology,

Pharmaceutical Manufacturing, Industrial Pharmacy, Medicinal Chemistry, Instrumental and Biomedical Analysis.

ACADEMIC PROJECT:

Validation Engineer

• Prepared and executed IQ, OQ and PQ protocols for manufacturing equipments.

• Prepared validation report including deviations observed during the execution of validation protocol and

provided with resolutions.

• Studied different cleaning agents for cleaning process development.

• Developed swab sampling method and analyzed swab samples for cleaning validation.

• Prepared and validated electronic spreadsheet for content uniformity data entry as per the FDA

requirements.

WORK EXPERIENCE:

Swiss Pharma LTD, Ahmedabad, Gujarat, India JULY 2009 to DEC 2010

Quality Control Chemist

Responsibilities includes,

• Worked under cGMP area and follows SOP’s, familiar with cGMP/GLP and ICH/21 CFR part 11, 210, 211,

820 guidelines, change controls and warning letters 483’s.

• Performed analytical chemistry assay as per cGMP compliances based on new and existing methodologies

by operating analytical instruments such as HPLC, FTIR and UV to analyze raw materials, productions

intermediates and final products.

• Performed analytical testing such assay, impurities, dissolution, content uniformity, and blend uniformity,

physical testing of solid dosage forms (tablets & capsules).

• Performed method validation and process validation and prepared reports based on data.

• Studied SOP’s, lab reports and batch documentation.

Cadilla Pharmaceuticals LTD, Ahmedabad, Gujarat, India AUG 2006 to AUG 2007

Analytical Chemist

Responsibilities includes,

• Performed qualitative and quantitative analysis of raw materials and active ingredients in process, finished

products and stability samples as assigned by using HPLC, GC, UV and FT IR.

• Prepared and maintained laboratory documents under the regulatory compliance.

• Data interpretation and written analytical reports and transferred to QC supervisor.

• Performed method validation as per the method validation protocol.

INTERNSHIP:

Centurion Laboratories, Vadodara, Gujarat, India APRIL 2006 to JULY 2006

• Accomplished an internship of 120 days, where I gained basic experience of working in quality control and

quality assurance which also helped me to establish an ambition of becoming an Analytical Chemist.

• Supervised manufacturing and packaging of tablets, capsules and parenterals.

• Performed analytical testing such as assay, test of purity, dissolution, disintegration, content uniformity,

hardness, friability and titrations for tablets.

• Assembled and weighted materials and supplies.

PROFESSIONAL DEVELOPMENT:

• Presented on validation of inhalation aerosols, validation master plan and its FDA consideration.

• Presented on project management for new manufacturing facilities of pharmaceutical products.

• Presented on design of each unit operation in tablet manufacturing facility.

• Attended Indian Pharmaceutical Congress, a national level symposium at Nirma University, India.

• Attended seminars as an active member of ISPE and PME group.

• Selected as a Best Student of the year 2005 during bachelor of pharmacy.

REFERENCES: Available upon Request

I will be privileged if you can call me for the personal interview to prove my worth.

Thanking you,

NILESHKUMAR KOTADIYA

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