Usha Devi
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Usha Devi Email & Phone Number

Sr. QA Clinical at Bio Pharma Services Inc. at BioPharma Services Inc.
Location: Toronto, Ontario, Canada 7 work roles
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Current company
Role
Sr. QA Clinical at Bio Pharma Services Inc.
Location
Toronto, Ontario, Canada
Company size

Who is Usha Devi? Overview

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Usha Devi is listed as Sr. QA Clinical at Bio Pharma Services Inc. at BioPharma Services Inc., a company with 251 employees, based in Toronto, Ontario, Canada. AeroLeads shows a matched LinkedIn profile for Usha Devi.

Usha Devi previously worked as Sr. QA Clinical at Biopharma Services Inc. and QA Reviewer (Medical cannabis) at Contract Lab.

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BioPharma Services Inc.

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Profile bio

About Usha Devi

Graduate in Bachelor of pharmacyHPLC techniques for identification and assay of finished products and system suitability. Titrations, extractions, filtration, Thin layer chromatography, paper chromatography. Finished product test including dissolution, limit test, heavy metal tests, % LC Raw material testing including %Assay, tap density, bulk density, content uniformity, loss on drying and residue on ignition. Waters HPLC along with millennium software, UV, IR spectrophotometer, Karl fisher titration.• Able to effectively apply various techniques such as Dissolution, IR, UV, TLC, HPLC and Karl Fischer• Experience in the performance of many analytical tests such as Friability, particle size, content uniformity, Hardness, LOD, Bulk and Tap Density and preparation of Test solutions dilutions and standardisations• Knowledge of GMP/GLP and experience working in regulated environments• Accustomed to working in the compendial methods such as USP, BP, EP and in house methods (SOPs)• Accurate and auditable reporting based on the data reporting requirements within the certificate of analysis Autoclave, hot air oven, incubator and biological safety cabinets Preparation of TS, VS solution from stock solution. Knowledge of regulatory affairs, NDA ANDA, NDS and CTA. Documentation and planning for CAPA Change control and Compliance. Preparing reports for OOT, OOS according to SOPs. Auditing( GMPs , GLPs,) along with reporting observations.Knowledge in Technical Writing.

Listed skills include Hplc, Quality Assurance, Laboratory, Change Control, and 19 others.

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Usha Devi's current company

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BioPharma Services Inc.
Biopharma Services Inc.
Sr. QA Clinical at Bio Pharma Services Inc.
toronto, ontario, canada
Employees
251
AeroLeads page
7 roles

Usha Devi work experience

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Sr. Qa Clinical

Current

Canada

  • conducted audits of clinical trials for compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, Health Canada, EMEA, etc.)
  • Reviewed Protocols and Informed Consent Forms (ICF)
  • Audited pre-study documentation, in-process activities, end-of-study documentation, clinical databases and clinical study reports.
  • Conducted various corporate audits, including audits of equipment maintenance, training records and computer validation.
  • Keep Management up to date with findings and follow up on corrective actions.
  • Assisted in the review, writing and distribution of SOPs.
Dec 2020 - Present

Qa Reviewer (Medical Cannabis)

Current
Contract Lab

Ontario, Canada

Dec 2019 - Present

Quality Assurance Co-Op

Fresenius Kabi Toronto

Markham

Sep 2015 - Dec 2015

Quality Assurance Analyst

Scarborough, Toronto, Canada

  • Excellent understanding of applicable Health Canada, FDA, ICH and GMP/GLP regulations and guidelines
  • Demonstrated good documentation practices as per cGMP and GDP guidelines
  • Trained on writing deviation reports, out of specification (OOS) reports, change control reports and CAPA; based on available data ensuring compliance with regulatory affairs
  • Knowledge of regulatory compliance activities to enforce quality assurance policies and best principals regarding quality, safety, design, production and inspection
  • Complied and presented NDA and ANDA documents
  • Presented ICH guidelines on dose-response information to support drug registration
Jan 2015 - Dec 2015

Trainee

Bengaluru Area, India

Trained in various techniques of analysing the multivitamins.Analysis of raw materials and finished products of multivitamins.

Jun 1994 - Sep 1994

Trainee

Bengaluru Area, India

Analysed finished product and raw materials,following sop, USP and IP methods.Documenting the data and organising the lab.Arranging the glass ware and learned the latest techniques.During the training we were exposed to manufacturing area also.

Jun 1993 - Sep 1993
Team & coworkers

Colleagues at BioPharma Services Inc.

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FAQ

Frequently asked questions about Usha Devi

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What company does Usha Devi work for?

Usha Devi works for BioPharma Services Inc..

What is Usha Devi's role at BioPharma Services Inc.?

Usha Devi is listed as Sr. QA Clinical at Bio Pharma Services Inc. at BioPharma Services Inc..

Where is Usha Devi based?

Usha Devi is based in Toronto, Ontario, Canada while working with BioPharma Services Inc..

What companies has Usha Devi worked for?

Usha Devi has worked for Biopharma Services Inc., Contract Lab, Pharma Medica Research Inc., Fresenius Kabi Toronto, and Academy Of Applied Pharmaceutical Sciences.

Who are Usha Devi's colleagues at BioPharma Services Inc.?

Usha Devi's colleagues at BioPharma Services Inc. include Janella Knyzel Tutanes, Tefemary-Geordia Ferrer, Fathi Abuzgaya, Vayisnavei Gnanamanogaran, and Patricia Polisena.

How can I contact Usha Devi?

You can use AeroLeads to view verified contact signals for Usha Devi at BioPharma Services Inc., including work email, phone, and LinkedIn data when available.

What skills is Usha Devi known for?

Usha Devi is listed with skills including Hplc, Quality Assurance, Laboratory, Change Control, Microsoft Word, Research, Microsoft Office, and Leadership.

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