DHRUVI MISTRY

*** ****** ****, **** **********, MARYLAND 20744

Email: addwgv@r.postjobfree.com Phone: 240-***-****

PROFILE

Masters in Pharmaceutical Science with exceptional leadership, problem solving, communication and Research skills; seeking a job in Pharmaceutical Industries in the suitable area and position.

PROFESSIONAL EXPERIENCE

THEMIS MEDICARE LTD.- Gujarat, INDIA March 2018 – June 2019

QA Officer

Prepared and reviewed Standard Operating Procedures (SOP).

Helped officers of research department to prepare Batch Manufacturing Record (BMR) and Batch Packing Record (BPR).

Issued BMR and BPR as per BMR/BPR/Protocol Requisition slips.

Reviewed BMR and BPR as per approved check list.

Batch released in ERP (Enterprise Resource Planning) system.

Issued Quality Control protocols for Raw Materials, In-Process and Finished good.

Checked and reviewed Specifications and Standard Testing Procedure of raw materials, in-process and finished good.

Handling and kept records of Change Control, Planned/Unplanned Deviation.

Prepared and reviewed Annual Product Quality Review (APQR), Site Master File (SMF).

Performed Line Clearance activity at production, packaging and store department.

Checked and approved product labels before dispatch.

Practiced Good Manufacturing Practice (GMP).

Checked and reviewed logbooks of calibration of instruments and equipment in QC and production departments.

Assisted in weekly inspection in QC, production, store department to keep track on Good Laboratory Practice (GLP)

Supported investigation/CAPA activities relating to product release such as conducting and producing investigation reports, maintain records of CAPA.

Kept records of meetings related to department activities.

NEEL NAYAN PHARMA PVT. LTD.- Gujarat, INDIA October 2016 – February 2018

QA / IPQA Chemist

Reviewed and control of Standard Operating Procedures (SOP).

Performed daily and weekly calibration activity of on the floor.

QA overviewed for clean room behavior.

Checked and reviewed calibration record of QC, production, store department.

Issued and maintained daily, weekly, monthly and yearly logbook to all departments.

Prepared, issued and reviewed BMR and BPR, filled IPQA activity in BMR and BPR.

Reviewed all documents relating to manufacturing, packaging and analysis report prior to batch release.

Line clearance and performed IPQA activities for dispensing, manufacturing, packaging and warehouse area.

Practiced GMP and GLP.

Handling and kept records of Change Control, Planned/Unplanned Deviation.

Performed activities assigned by QA manager.

KLE UNIVERSITY’S COLLEGE OF PHARMACY- Karnataka, INDIA September 2014 – August 2016

Research Scholar

Literature review related to research topic.

Performed research on investigation and development of solid lipid nanoparticles for antihypertension drug. (worked on High Pressure Homogenizer, Ultrasonicator, UV-Spectroscopy, Rotary Evaporator, Differential Scanning Calorimetry (DSC), HPLC)

Assisted research professor for their scientific work.

Guiding and helping research student for their research work.

EDUCATION

KLE University, Karnataka, India

Masters of Pharmacy August 2012 - May 2014

U.S. Equivalence: Master of science in Pharmaceutical Science with specialization in Quality Assurance

Thesis: “Simultaneous Estimation of Losartan Potassium and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Form by High Performance Liquid Chromatography (HPLC)”

KLE University, Karnataka, India

Bachelor of Pharmacy August 2008 - May 2012

U.S. Equivalence: Bachelor of Science with major in Pharmaceutical Science

SKILLS

Good skills of Quality assurance, analytical development and formulation.

GMP, GLP working environment.

Knowledge of computer system

Experience of planning and organizing work

Documentation

PROFESSIONAL ASSOCIATION

Registered Pharmacist in India (RPh)

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