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Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Apotex
Designation : Research Scientist
Function : R&D
Functional Area : Analytical R&D
Job Role Summary : Under guidance of Supervisor or senior chemist, responsible for performing all activities in ARD-Test Centre including method validation for new products, full testing of API, in-process and finished dosages, and generates regulatory submission documentation.  Acts as a key member in the project working team.
Job Profile :
  • Performs validation of analytical testing procedure for drug substance and drug product.
  • As per specifications, performs initial testing as well as testing of stability samples, in-process and raw materials.
  • Conducts other tests required for dosage submissions.
  • Documents and reports results as per established SOP’s.
  • Provides technical support to other department in response to deficiency letters from regulatory agencies.
Job Requirements :
  • Experience: BSc with 5 years or MSc with 3-4 years’ experience in a pharmaceutical lab in an R&D environment.
  • Knowledge of wet chemistry, analytical bench techniques, Window-based software.
  • Knowledge of automated data acquisition systems is an asset.
  • Knowledge of Auto/Manual dissolution test is an asset.
  • Working knowledge of GC is an asset.
  • Good written and verbal English communication skills.

 

Work / Job Experience : 3-5 Years
Type of Experience : Analysis of drug product, developmental samples, stability samples, Method Validations
Academic Qualifications :

A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.

Website Linkedin Apotex

To apply for this job please visit careers.apotex.com.