Resume

1. Margesh J. Shah
300W Munsell Ave, Linden, NJ-07036
margesh444@gmail.com Ph.: 1862-371-3188
SUMMARY
To achieve a position in the pharmaceutical industry that will utilize my practical skills and academic
knowledge. I am looking forward to a career full of challenges and responsibilities which would give me a
sense of satisfaction and accomplishment and would offer me immense opportunity for my intellectual and
professional growth.
Degrees & Certifications
MS in Pharmaceutics (Industrial Pharmacy) from Long Island University, Brooklyn, NY, USA
2009-2011
Bachelor of pharmacy Pune University, India
2004-2008
Professional Work Experience
Soma Labs Inc. USA
QC Chemist
(2013-Present)
• Perform sampling, Evaluation of API (Active Ingredients), in-process and finished products
using different equipment using different laboratory instruments as per FDA 21CFR Part 111
requirements.
• Sample and perform a variety of inspections and tests on raw materials, in-process and
finished product, packaging, printing, labeling, numbering, and coding.
• Worked under current Good Manufacturing Practices (cGMP) and Good Laboratory Practices
(cGLP).
• Review and approve the product specifications established in accordance with certificate of
analysis (COA) and Master Manufacturing Record (MMR).
• Proficient in reviewing Analytical Report and performing the batch release based on
documentation in accordance with compliance to the established standards.
• Reviewing Documentation including OOS, updating SOP’s and performs training on the
same and GMP work instructions.
• Assist in resolving complex issues regarding production with the QA director and implement
the CAPA to prevent re-occurrences.
• Maintain the retained product room and its inventory.
• Work in accordance with production and coordinate with packaging department.
• Testing and release of packaging material according to specifications.
• Verifying label against master label for its claim and other detailed information.
• Perform physical testing using hardness tester, caliper and disintegration apparatus.
• Sample and inspect product to ensure conformance to approve.
• Maintain complete and accurate records of analytical in-house and all outside testing
reports.
• Perform daily check and calibrations of analytical balances.
• Records entries in laboratory logbooks as necessary.
• Responsible for ensuring safety and integrity of product testing in the department.
• Interprets and evaluates data in terms of accuracy, precision, trends, and potential GMP
impact and recommends appropriate corrective action where necessary.
• Performs, documents, record checks, and troubleshoots qualitative or quantitative issues.

2. • Manage and performed In-process Quality Control by interacting with the different
departments such as Product Development and R&D.
• Proper handling of Allergen products and equipment according to Allergen Control
Procedures. Also perform allergen testing to ensure validation of cleaning procedures for
production equipment.
Pharmacy Supervisor
(2012-2013)
• Manage people working with the initial stage of production including Pharmacy operations
(weighing) and material processing (blending).
• Supervise them through assigning, directing and following up of all activities of processing.
• Manage and train operators in the team regarding their key responsibilities.
• Meet the productivity, quality, safety, health, environmental and morale goals established for
the site.
• Make recommendations for long term solutions, including recommendations for replacing
equipment, refurbishing equipment, procedural changes, productivity improvement, material
change, etc., related to the area of accountability.
• Tablet manufacturing includes, Granulation (Dry Granulation and Wet Granulation)
• Document manufacturing and processing of products in conformance with established
methods and procedures.
• Verify that manufacturing was performed according to the batch record while following
SOP’s and cGMPs, and that all data are documented and reported are or not in conformance
with the established standards.
Lupin Pharmaceuticals, India
Marketing Executive
2008-2009
● Meeting Doctors Regarding products.
● Evaluation of Prescription.
● Performed regular Market Research.
● Detailed knowledge of the product.
● Achieved a sales target every quarterly for our area.
Unicure Remedies, India
Quality Control Department: Trainee
(2006-2007)
● Worked under GMP and aseptic environment.
● Handling and proper understanding of all the equipment’s. HPLC, UV-vis spectroscopy, FTIR,
Dissolution apparatus.
● Testing and Evaluation of Pharmaceutical and Cosmetics Raw materials.
● In-process Quality Control and Production Batch testing.
● Documentation works including Reporting to the supervisor, writing SOP’s and review them for
completeness.
Experience with Instruments:
● Handling and proper understanding of HPLC.
● Worked with various Analytical Instruments such as UV-vis Spectroscopy, FTNIR,

3. Dissolution apparatus, and Disintegration apparatus.
● Also experienced in quantitative and qualitative analysis using wet chemistry techniques such
as titrations and Karl Fischer Apparatus.
● Testing and Manufacturing of various Dosage Forms (In process and Final Product)
● Evaluation of tablets including:
● Hardness Test
● Friability Test
● Disintegration Tests
● Dissolution Test
● Weight and Content Uniformity using UV and HPLC equipment’s