Quality Control Development
Resume:
RAJVI PATEL
CONTACT: 516-***-****
EMAIL: ************@*****.***
OBJECTIVE
Have a great urge and motivation backed by professionalism and commitment, to be a successful Research scientist in pharmaceutical and healthcare industries.
PROFESSIONAL EXPERIENCE (OVERVIEW)
Amneal Pharmaceuticals, USA April 2007 – Present
Located in NY, Amneal Pharmaceuticals is a manufacturer, developer and marketer of high quality generic and over-the-counter pharmaceuticals.
Working as: Analytical Chemist
Sun Pharmaceutical Advanced Research Center (SPARC), India August 2006 - March 2007
SPARC is the first research center of internationally well-known and one of the leading pharmaceutical company Sun Pharmaceuticals and formally inaugurated by Dr. A P J Abdul Kalam, the Hon. President of India in Dec. 2004.
Worked as: Trainee Research Assistant
Bioarc Research Solution (a.k.a. Alembic Research Center-ARC), India May 2006 - July 2006
ARC is, ISO-9002 and ISO-14001 certified, Asia’s most respected pharmaceutical company with WHO-GMP guidelines conformed manufacturing practices and facilities and it has business over 75 countries around the world.
Worked as: Research Associate
Cadila Healthcare Ltd. (Zydus Cadila), India March 2003 - July 2004
The fifth largest pharmaceutical company in India and with US$290m in turnover. Cadila Healthcare Ltd. manufactures a large range of pharmaceuticals as well as diagnostics, herbal products, skin care products and other OTC products.
Worked as: Technical Supervisor
EDUCATION
• Master of Pharmacy, The M.S. University, Gujarat, India. 2004-2006
Dissertation in “Bioanalytical method development of Paroxetine in Human plasma by HPLC-MS/MS”.
Received second rank in University with gold medal in Masters of Pharmacy.
• Bachelor of Pharmacy, L.M. College of Pharmacy, Gujarat, India. 1998-2002
Received Dr. C. S. Shah Pharmacy memorable award in Pharmacognosy with second rank in university.
PROFESSIONAL SKILLS
• A detail oriented, sincere, hard-working individual with Master degree in Pharmacy and having more than 4 years of experience in pharmaceutical industry with successful records of chemical and instrumental analysis, method-development and validation, preparation and review of SOPs as per cGMP and GLP guidelines.
• Hands on experience in handling and calibration of sophisticated instruments like HPLC Shimadzu (Class-VP and LC-solution 1.21) with UV/PDA detector (LC 2010A and auto injector), Agilent 1100 series (Hewlett Packard), Perkin Elmer and Waters (Empower 1.0 software) and HPLC-MS/MS - API-2000, API-3000, API-4000 (with Analyst software 1.2.1 and 1.4.1), Thermo – Ultra and Discovery (with TC Quant software).
• Hands on experience in handling and calibration of instruments like Differential Scanning Colorimeter (Perkin Elmer), UV/Visible Spectrophotometer (Shimadzu), Dissolution test apparatus (Electro lab, Lab India, Vankel, Varian, Hanson research with online UV/Visible spectrophotometer), FTIR (Perkin Elmer and Nicolet Impact 400D), KF titrator (Metrohm).
• Analytical and bioanalytical method development, validation and study sample analysis as per ICH/USFDA guidelines.
• Comprehensive knowledge of ICH, SUPAC and USFDA guidelines.
• Well acquainted with cGMP, GLP, GCP and FDA safety guidelines followed and implemented in pharmaceutical industries.
PROFESSIONAL EXPERIENCE (DETAIL)
Amneal Pharmaceuticals, Hauppauge, NY, USA
Analytical Chemist April 2007 - Present
• Working in finished product team.
• Performing physiochemical and chemical analysis on analytical samples as per established STP and familiar with trouble shooting technique. Performing in-process Quality control tests of finished product and customer complain samples as per STP like assay, content uniformity, weight variation, dissolution, IR, moisture, friability etc.
• Operation, Calibration and trouble shooting of pH meter, analytical balance, HPLC, UV/Visible Spectrophotometer, Dissolution test apparatus, FTIR.
• Strong knowledge of GC, GLP and GMP guidelines.
• Operation of KF titrator with water factor determination.
Sun Pharma Advanced Research Center (SPARC), India
Trainee Research Assistant August 2006 - March 2007
• Actively worked in Bioequivalence department.
• Involved in bioanalytical method development, validation & plasma sample analysis of human subjects as well as animal subjects (pre-clinical study) for NCE.
• Operation, calibration and trouble shooting of HPLC-MS/MS.
• Prepared and reviewed draft method SOP for validation, method SOPs for study sample analysis, templates for method validation & study sample analysis.
• Reviewed data of IQ/OQ/PQ of HPLC and MS/MS.
• Reviewed validation report and study sample analysis report.
• Supported actively in internal QA and USFDA audit.
Bioarc Research Solution (Alembic), India
Research Associate May 2006 - July 2006
• Served actively in Bioanalytical department.
• Involved in method development, validation and subject sample analysis.
• Operation, calibration and trouble shooting of HPLC - MS/MS.
• Prepared and reviewed draft method SOP for validation and method SOPs for study sample analysis.
• Prepared and reviewed templates for method validation and study sample analysis.
• Reviewed raw-data of method validation and study sample analysis.
• Prepared and reviewed SOPs.
• Prepared and reviewed validation report and study sample analysis report.
Cadila Healthcare Ltd. (Zydus Cadila), India
Technical Supervisor March 2003 - July 2004
• Served in ADL-Analytical Development Laboratory in France and Domestic teams.
• Operation, calibration and trouble shooting of HPLC, dissolution test apparatus.
• Developed analytical methods on HPLC and UV for new drug products for assay, related substances, dissolution profiles etc.
• Performed analytical method validations against protocols for new drug products developed for regulated markets.
• Performed stability testing of finished products of various dosage forms as per ICH guidelines.
• Actively involved in France project finish product method development.
REFERENCE
References will be provided on request.
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