Ranjit Parajuli (US Citizen)

203-***-**** adcs5u@r.postjobfree.com

Skills

ISO 9001, ISO13485, FDA QMS, EPR, BPCS

CAPA, FMEA SPC, SOP, STP

CGMP, GLP, 5s/6s, MSDS Empower, LIMS

Microsoft office Assay, Western Blots

HPLC, UV, FTIR Dissolution, Stability, sterility

Education

University of New Haven West Haven, CT

Master of Science Industrial Engineering Dec 2020

Tribhuvan University Kathmandu, Nepal

Bachelor of Science Apr 2015

Certification

Six Sigma Green Belt Dec/2018

Diploma in computer application Jul/2012

Experience

Protein Science a Sanofi Company Meriden, CT

Quality Control Analyst II 02/19-Current

Performing western blot, SDS page, Electrophoresis of proteins.

Performed Environmental monitoring of GMP class 100,1000,100000 rooms.

Scope out capital projects to improve operating condition in the material handling department and kept all department procedure up to date.

Identify, analyze and document problems to Improve efficiency of the products.

Trelleborg Engineered Coated Fabric New Haven, CT

Polymerization Specialist/ Quality Engineer 8/18-02/19

Implemented Lean Manufacturing tools & techniques (workshops, kan-ban, visual management, 5S, total productive maintenance, set-up reduction, etc.

Monitored the current work procedure and investigate to apply lean manufacturing for the opportunities for waste reduction.

Completed Root Cause analysis and implement CAPA using formal problem-solving techniques including Lean Six Sigma tools.

Helped oversee and develop manufacturing standards, including machine capacity, quality control, tools and equipment, pathways and cycle times

Build quality systems and creates standard operating procedures (SOP).

Medtronic (Kelly Services) North Haven, CT

Quality Assurance Tech. 2/17-06/18

Maintained Non-Conforming Material Report (NCR) system per procedures.

Implemented, planned and systematic processes that support the development and administration of a Quality System compliant to FDA, and ISO requirements

Performed other duties as needed to ensure compliance with relevant FDA and ISO regulations.

Applied best effort to maintain standard quality for the surgical products, using various quality tools such as, AGILE, SOP’s, root cause analysis and many more.

Acquired, analyzed, and documented chromatographic data following cGMP and corporate directives/SOPs.

Developed inspection criteria for components and finished devices inside the ISO Class 8 Clean Room.

Asian Pharmaceuticals Pvt.Ltd(Baniya Group) Rupandehi, Nepal

QC Chemist 2/13-5/16

Develop inspection criteria for components and finished devices inside the ISO Class 8 Clean Room.

Test performed under routine analytical testing for stability samples, evaluating and documenting results in a timely manner, followed by the all SOPs and written Standard Test Procedures (STP)

Performed Analytic analysis by USP, BP, IP and in-house test methods using HPLC(Empower), TLC, UV, IR and Wet Chemical techniques of solid dosages form.

Calibrated various instruments such as pH meter, Dissolution apparatus, Gauge Meter, hardness tester, disintegration tester, analytical balances, Karl Fischer& UV-VIS Spectrophotometer

Various test analysis of API, Excipients and other Raw materials followed by USP, BP and IP Record all results into the computer system (LIMS and Empower).

Performed process quality control tests for tablets including dissolution tests, disintegration tests, weight uniformity tests, tablet thickness tests etc. under cGMP and GLP environment.

Berger Paints LTD Hetauda, Nepal

QC Chemist 10/11-1/13

Inspect Sets up and mixing process to meet company and product specifications.

Accurately completes all required documentation and maintains ISO traceability requirements.

Assists and/or leads chemical waste reduction initiatives.

Assist with the coordination of activities for employees engaged in the mixing process, inspects material, product, or equipment to identify defects or malfunctions.

Observes, monitors and validates mixing processes to ensure employees understand and meet production or processing.

Tried to find out causes based on customers complains.

Inspection for the ISO, MSDS,5S, DHR.

Visual and functional examine for titration and other tests.

Languages Spoken: English, Nepali, Hindi, Urdu

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