About this job
- Industry: Pharmaceutical
- Area of expertise: Regulatory
- Location: Montreal
What is required?
- Hours per week: 40
- Education level: Academic Bachelor
- Closing date: Saturday, 2 October 2021
About this role
About this role
We are currently hiring a Quality Assurance Manager for our client who is a specialty pharmaceutical company focused on innovative prescription pharmaceuticals globally. This is a permanent full-time opportunity based out of Montreal, Quebec. Reporting to the Quality Associate Director Canada and Latam, the QA Manager will assume responsibilities to ensure the compliance of pharmaceutical products in Canada as well as to maintain quality compliance with Good Manufacturing Practices (GMP) and the company Standard Operating Procedures (SOPs).
- Represent the company as the Quality Person in Charge (QPIC) for Health Canada.
- Expand internal processes for the development of the people from Quality Assurance department.
- Generate of annual product quality review.
- Review Quality Agreements.
- Manage of Deviations and CAPAs.
- Coordinate the timely collection of GMP evidence with corporate partners for product specific updates of Drug Establishment License.
- Maintain Site licenses and prepare related amendments and notification to Health Canada.
- Manage the lot release of pharmaceutical and natural health products to the Canadian market.
- Manage the changes made to marketed products.
- Handle marketed product complaints, in collaboration with corporate partners.
- Participate in on-site Health Canada GMP audits and, as required, conducting inspections of suppliers involved in the manufacturing and/or distribution of pharmaceutical and natural health products.
- Act as the qualified person for quality compliance matters raised internally, by suppliers or corporate partners.
- Coordinate any required product recall procedure as per internal SOPs.
- Participate in the preparation of CTD modules or responses related to the Chemistry and Manufacturing component of a regulatory dossier.
- Evaluate processes, results, operations, and trends to ensure compliance with local and international standards related to GMP, GLP, GDP. GSP, GPP.
- Review quality KPIs and reports.
- Support the implementation of the Quality Management System (software QMS).
- B.Sc, M.Sc or PhD in Science
- Minimum of 6 years within the pharmaceutical industry, including Quality Assurance
- Strong scientific knowledge.
- Excellent communication skills; written and oral English; Spanish is desirable.
- Strong knowledge of Microsoft Office Suite.
- Experience in People Management is desirable.
Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
How to apply
How to apply
If you meet the above requirements and would like to be considered for this role, please submit your interest using the ‘Apply’ button. Applying is quick and easy – just make sure you have the following documents ready to go:
- Cover Letter (optional)
Do you have questions?
If you have questions or would like to discuss the details of this role, please contact Chris Kapusta via the details below, quoting publication number:
Brunel Canada - Calgary