Quality Assurance Technician

Siddharth Sapa

** ******** ****, **********, ** 08854 201-***-**** ******@*****.***

Objective:

Seeking a full time job where I can utilize my knowledge from academic and pharmaceutical training and learn more skills in drug development in the pharmaceutical Industry.

Education:

• Master of Science in Pharmaceutical Science. May - 2009

Long Island University, Brooklyn, New York

• Bachelor of Pharmaceutical Science May – 2005

Rajiv Gandhi University of Health Sciences, India

Experience:

Quality Assurance Associate January 20012-Present

US Pharma Lab, NJ

• Issue Master Batch Record and supporting documents for the manufacturing.

• Audit internal quality system elements in manufacturing and operational support areas as per GLP and GMP under FDA regulated environment.

• Review and approve deviations/investigations/CA-PA for special projects.

• Perform release of raw material for use in cGMP manufacturing.

• Ability to ensure Room and Line clearance on product change over.

• Responsible for review completed Master Batch Records for completeness and accuracy prior to product release.

• Perform compiling and release of executed batch records.

• Responsible for Release of finished product.

• Release/clear products in electronic inventory systems.

• Scanning and filing of QA related documents, maintain Log Books and data base.

Lab Assistant

Long Island University, Brooklyn, NY January 2007 - May 2009

• Formulation development of skin care product like sun screen lotion, zinc oxide ointment, skin care cream and lotion on laboratory scale.

• Testing raw materials to determine viscosity, particle size, solid content, bubbles etc. using available instruments.

• Development of Solid, Semi Solid dosage and enteric coated dosage form in small scale.

• Method development and validation for different novel APIs as per USP under GMP

• Studied the dissolution of different formulation and analyze the results using HPLC and UV/Vis spectrophotometer.

• Used standard word processer and spreadsheet applications of Microsoft Office to finalize the results and reporting of final results through presentations to other team.

Pharmacy Technician December-2009 – April-2010

Target Pharmacy, Rockville, MD

• Worked as a Nationally Certified Pharmacy Technician

Pharmacy Technician April 2010 – January 2012

Correct Rx Pharmacy Services, Linthicum, MD

• Worked as a Nationally Certified and State Registered Pharmacy Technician.

Torrent Pharmaceuticals.

Research Assistant January 2005-December2005

• Solid dosage formulation and process development under GMP regulations.

• Utilized HPLC and Gas Chromatography to analyze final drug products.

• Conducted accelerated stability studies for various dosage forms according to GLP regulations.

• Developed product specifications by evaluating physical/chemical properties of raw materials and formulations (viscosity, specific gravity, microscopic examination, pH etc).

• Quality control of small volume parental (Injectable & Ophthalmic), tablets and capsules.

• Collaborated with cross functional teams for product support.

ANALYTICAL TECHNIQUES/INSTRUMENTATION

• HPLC.

• UV- VIS spectrophotometer.

• Dissolution Apparatus 1 and 2.

• Tablet compression, coating and packaging equipments,

• Capsule filling and packaging equipments

Additional Skills:

• Proficient in Microsoft Office (Word, Excel, Power Point).

• Good knowledge of GMP.

• Strong written and communication skills.

• Very accurate and legible documentation skills. Strong analytical skills.

• Ability to work in a fast-paced environment with multi-tasking skills.

• Very good team player as well as can works independently with strong work ethics. Can do attitude. Quick Learner.

• Very good database management, organization and record keeping skills.

• Active member of American Association of Pharmaceutical Scientists, (AAPS).

Course Work:

Bio pharmaceutics and Pharmacokinetics, Pharmaceutical Analysis, Industrial Pharmacy I and II, Physical Pharmacy, Physical Chemistry, Pharmaceutical and Cosmetic Raw materials, Cosmetic Science, Dosage forms Design. Pharmacology and Toxicology I and II, Medicinal Chemistry I and II, Pharmaceutics, Microbiology and Biotechnology, Instrumental and Biomedical Analysis, Bio-pharmaceutics and Pharmacokinetics, Applied Biochemistry, Advanced Industrial Pharmacy, Path physiology, Anatomy and Physiology, Pharmaceutical Engineering, Pharmaceutical Organic Chemistry I and II.

Reference: Available upon request. * Open to Relocate.

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