Shailesh Rana

** **** **** **. *******, NJ ****3■ Phone: 973-***-**** ■ E-mail: ac8jrm@r.postjobfree.com

Career Objective:

Seeking a challenging career as a “Quality Inspector” or “In-Process Inspector” in medical device and pharmaceutical industries where my experience, education & interests can be utilized for mutual benefits for both the company & myself.

Professional Experience:

Stryker Orthopedic

OPS Quality Assurance May 2017– January 2019

On a daily basis, I inspect the products made to hit target numbers for overall success.

Reviews routers to assure that the quantity, size, and shape information is correct recorded.

Must also ensure that all routers are put in its proper sequence.Reviews and read blueprint,CMM report useing gauges and callipers and micrometers.

Sends defective routers and parts into “quarantine “or hold system.

Must make a document on defective items and sends them to the Quality Head's Office.

I ensure that the Inspection Guide Sheet/Subpages/ Parts and Lot Number/ Revision number are in proper place and order. Contributes to teams objectives and overall goals at daily meeting.

Fully trained to check whether the document has a Certificate of Compliance, Packing/Order List, Heat Parameter Sheet and Device History Record. Calibration and Maintenance of instruments in accordance with SOPs & CGMPs.

Nutra-Med Packaging Inc. August 2016 – May 2017

Inventory/Stock Coordinator

Inspects incoming components sent by the suppliers and visualize the inspection.

Counts the quantity and quality of the product given.

Relocate the component materials and enter the data into a database.

Ensure all paperwork matches with the component materials given by the supplier.

Informs Operation Managers about damaged or false components.

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Reed Lane - Packing Solutions Together January 2016 – July 2016

Quality Assurance / Incoming Material Inspector

Incoming inspection and approval of pharmaceutical product and all packaging components.

Prepare standards for all first time receipt material and monitoring temperature chart recorders throughout the plant and document in log daily.

Prepare and maintain customer bulk samples for retest and being responsible for all Hold stock status of bulk or components, including all paperwork.

Collect samples, documents for sample submission to customers, and prepare paperwork for outside contractor testing.

Photocopy all paperwork for the outside contractor testing and all paperwork pertaining to all receiving reports and distribute to Accounts and Payable and Inventory Control Departments.

Garden State Nutritional, Fairfield NJ.

Analytical/QC Technician July 2003 – Dec. 2015

Performing Analytical Development activities using FTIR, Dissolution, KF, Malvern particle Size analyzer, Atomic Absorption, Disintegration and Flourometer as per compendia Procedure (USP, NF)

Perform Wet Chemistry testing on API and Excipients including Loss on Drying, Residue on Ignition, Bulk and Tapped Density, Sieve Analysis, Viscosity and Specific Rotation.

Testing finished products, Raw materials, Stability samples and In-process samples performing Assay, Impurity, Identification Tests, Disintegration and NIR /IR Profile.

Calibration and Maintenance of instruments in accordance with SOPs

Perform Documentation as per SOP and GMP Regulations and compliance wire.

Sidmack Pharmaceuticals, E.Hanover, NJ

QC/QA Dispensing (Lab& documentation) April 1999 – May 2003

Preparation of Specification, Standard Test Procedures, Analytical Method Raw material and finish product, vendor qualification and reduced testing proposal for finished products and Certificate of Analysis for raw materials, Excipients, Finished Products and Packaging materials.

Revising and Reviewing Standard Operating Procedures and Standard test procedures as per Current Revision Bulletins, Current IRAs and Current Errata.

Analyzing Development products, finished products, Raw materials, Stability samples, Packaging materials, in process samples using FTIR,, Dissolution and disintegration .

Conducting Identification tests, Assay, Sieve analysis, Bulk and Tapped density, Uniformity of Dosage units, Dissolution Profiles, Disintegration, Karl Fischer, thin layer chromatography, IR and Spectroscopy and documentation of same according to Standard Operating Procedures and Standard Test Procedures.

Handling of laboratory instruments, Test solutions and chemicals used for analysis.

Metam Corparation

Technician September 1994 – February 1999

Hands on experience in Electronic turbines & parts, processing and labeling.

Entering procedures in the computer, verify the value and quantity results any.

Maintaining data profile and helping counseling and dosage directions.

Continuous follow up with dispatch department for on-time delivery

Inventory management for silicones and offset printing

Coordination between customer, sales and dispatch department

Creating new customers by telemarketing

Education:

B.K.M. science college,, India

2rd years B.sc. Valsad, india.

Technical &Software Skills:

Software Skills: Empower as well as Microsoft Office and Internet Tools

Analytical Skills: FTIR, Disintegration, Malvern particle Size,vit, c,Tap/bulk density

Used Micrometers Calipers and Gage pins

References:

Available upon request

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