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: [email protected] 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.