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Quality Tester Resume

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OBJECTIVE: Seeking a job to utilize my ken in the field of Pharmaceutical Sciences and Clinical Research, and my proficiency in problem solving and analysis.

EDUCATION:

Master’s Degree of Science in Industrial Pharmacy
Bachelor’s Degree of Pharmaceutical Sciences

LAB EXPERIENCE:

  • Application of Physical chemistry, Organic chemistry, and material science during formulation development, and during course work and thesis project.
  • Familiar with lab techniques: Dissolution, Disintegration, Impurity assay related to Tablets & Capsules, Spectrophotometry.
  • Expertise in Chromatography techniques: TLC chromatography, HPLC, GC, FTIR, NMR.
  • Excellency in Titrimetric analysis, Extraction, KF, Cleaning techniques, and Assays, Wet Chemistry, Loss on Drying, Calibration of instruments, microscopy, calorimetry.
  • Hands on experience on Franz-Chin Diffusion cell, Bath circulator, Double beam spectrophotometer, Hot plate stirrer, Lightnin mixer, Hot air oven, Autoclave, Viscometer, and equipment typically found in formulation labs.
  • Lab work experience in formulating Topical products and in-vitro study design of the products and expertise in study data parameters related to topical products.
  • Lab working experience in formulation of different cosmetics (skin care, hair care products).
  • Experience in formulation of emulsions, suspensions, use of different surfactans, liquid materials.
  • Thesis work on Transdermal Drug Delivery Systems and presented seminar on Novel Drug Delivery Systems.
  • Batch Production techniques: Mixing, Blending, Drying, Punching, Coating of dosage forms.
  • Lab work experience according to cGMP and GLP guidelines.
  • Excellent skills in communication, presentation, and event organizing, multi tasking, quick learner.
  • Diploma course in Computers: MS-Office (word, power point, excel) & DOS, Internet from S.M.LALL INSTITUTE, Mumbai.

PROFESSIONAL EXPERIENCE:

Confidential,NJ Oct ’11- Present

Quality Assurance

RESPONSIBILITIES
  • Follow current lab SOPs for testing bulk, raw materials, and finished goods and determine disposition per Reckitt Benckiser Quality procedures
  • Review technical documents for ensuring use of current documents - BOMs, Specifications, and Test Methods
  • Ensure supplier Certificate of Analysis for raws are received for each shipment, and tests meet with technical raw material specifications requirements
  • Prepare Certificates of Analysis for Reckitt Benckiser products when requested by external customers
  • Ensure readiness for ISO, Global, and Internal audits
  • Operate all lab instrumentation, to include verifications, calibrations, troubleshooting and maintenance
  • Provide batch adjustments and corrective actions to Processing in case of failure to meet specifications
  • Communicate with Sr. Chemist to update technical specifications as required
  • Ensure availability of current bulk and finished goods standards in the QA and Aerosol labs
  • Prepare and standardize lab reagents and solutions as needed
  • Assist Sr. Chemist with special projects
  • Maintain calibration and traceability documentation for externally calibrated instrumentation
  • Maintain record retention system for batch production sheets and raw material test results, and Certificates of Analysis for raw material receipts
  • Maintain retain retention system for bulk batches and raw materials
  • Follow Hazardous Waste, General Waste and Recycled Waste Management and Disposal procedures in lab and adhere to lab safety procedures and Chemical Hygiene Plan

Confidential, NJ May ’10- Sept ‘11
Designation: Scientist I

  • Responsibilities include evaluating drug substance, excipients, release and the stability of the product.
  • Maintain highest cGMP and SOP standards, and follow FDA regulations & guidelines.
  • Performed quantitative analysis of chemical intermediates and drug substances and drug products using USP/NF/EP and in-house test methods like spectrophotometric, wet analysis and dissolutions.
  • Performed method validation testing & analysis of pharmaceuticals using instrumental techniques like HPLC, GC, UV and Standard methods.
  • Responsible for preformulation activities, assist in scale up and execution of manufacturing sized R & D batches, routine lab work like executing R & D batch, completion of daily lab notebook and following GMP, assist in preparation of submission of document as per guidance by scientist, assist in preparation of documents for ADNA submission.
  • Manage all analytical development, qualifications, validations for active pharmaceuticals, excipients, dosage forms, testing, release activities and in-process analytical testing services in support of the formulation development department, development and optimization of new and existing analytical methods for qualification, release testing of products.

Confidential, NJ Oct ’09- April ‘10
Designation: Product Analyst

  • Create manual detailing requirements for getting certified as a pharmaceutical distributor in each state.
  • Prepare, submit and track licensing applications with relevant paperwork.
  • Assist the sales team in targeting the right customers by tracking usage.
  • Create reports to help executive team on strategic decisions.

Confidential,Brooklyn Campus, NY Sept ‘07- May ‘09

  • Worked as a Graduate Assistant in Pharmaceutical Sciences Dept. under the guidance of Dr.Cutie (division director of dept.)
  • Worked as a Graduate Assistant in the Special Education Dept. Job responsibilities include assisting students in the study & performing department’s official work. The skills required are time management, good communication skills as well as interpersonal skills.
  • Assisting students in their Pharmaceutical formulation labs, Analytical labs, application of chromatography techniques using HPLC, UV (single beam, double beam), etc.

Confidential,Mumbai, India July ‘06 – Aug ‘07
Designation: Process Associate

  • Job profile- Clinical Data Management
  • Client- GSK (oncology and respiratory studies)
  • Tool: In-Form (Phase Forward)
  • Review and understand the study protocol and the timelines.
  • Escalate any discrepancy in the clinical data to the DM study manager as appropriate.
  • Action study team feedback as required on the data.
  • Perform external checks, to handle manual discrepancies and action the same.
  • Review the resolved discrepancies and close where appropriate.
  • To ensure an error free, quality data with no open queries.
  • Attend relevant study teleconference with the GSK staff

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