Quality Assurance Specialist - Cmo

August 6 2018
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Bioanalysis, Chemistry, Pharmacokinetics, Pharmacology
Laval, QC

At Prometic, over 450 people work at saving lives, one role at a time. Located at the heart of the Cité de la Biotech in Laval, our Prometic Bioproduction Inc. division is blooming as we are currently developing a treatment for orphan diseases affecting children, made of plasma-derived proteins. Our treatment will allow these children to have a new pathway to hope.

 

To contribute to this revolutionary and innovative project, we are looking for a Quality Assurance Specialist, who will oversee all batch records received from our CMOs to ensure an exceptional compliance level in a cGMP environment.

 

The Quality Assurance Specialist will contribute to the team by:

  • Analyzing and reviewing all CMO-executed batch records in support of batch final release according to existing quality management system;
  • Identifying, verifying and investigating deviations and change controls, including satisfactory completion of corrective actions prior to batch release;
  • Managing all CMO-generated documentation, both physical and electronic;
  • Issuing final product release, including the issue of a Certificate of Release, or rejecting the batch if need be;
  • Completing audits at manufacturing level.

 

You are the right person for this role because:

  • You hold a bachelor's degree (BAC) in Chemistry, Biochemistry, Biology or Pharmacy;
  • You have at least 4 years of experience in a similar role and you can therefore avoid common traps and get satisfactory answers to your questions;
  • Your experience with CMOs helped you develop a strong understanding of manufacturing activities and of floor-based challenges in a GMP environment;
  • You are not intimidated by an environment with frequent priority shifts and aim at using your know-how and confidence to bring structure;
  • You always keep your final goal in mind and you can successfully engage your partners in achieving a high level of compliance;
  • You can express yourself in French and in English.

 

Prometic offers you:

  • A fantastic team who strives at doing things in the best possible way;
  • A casual environment;
  • A « start-up » culture that values autonomy, innovation and collaboration;
  • A competitive salary and benefit package, which includes participation in shareholding program;
  • A unique opportunity to change lives through your commitment and contribution.

 

Send us your resume right away to: **@********.com with the reference PBP-QA-1802.

 

The usual fine lines:

Prometic is an equal opportunity employer.  For more information about Prometic, visit our website  www.prometic.com.

Apply now!

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