Manager/Senior Manager, Analytical Operations
Praxis
Quality Assurance Lead/Senior Consultant – Importing
Q&C Services
full-time
Posted on:
Origin: • 🇨🇦 Canada
Visit company websiteJob Level
Senior
About the role
- This pharmaceutical consultant role focuses on applying your GMP knowledge and experience to various projects, such that the client is confident in the approach and timing of execution of the project. Our consultants work independently within a team environment to ensure activities are undertaken in a timely manner. This position may require onsite consultant engagements with in the pharmaceutical industry.
- We are looking for consultants who want to apply their in-depth quality and compliance knowledge and out-of-the-box thinking to challenging projects with our clients. Our projects cover, but are not limited to: deviation investigations, change controls, CAPA, auditing, management of quality systems, delivering of training, batch document review, product releases, related to the importation of pharmaceuticals, biologics, NHPs and Medical Devices.
- In this broad-based role, you will support the projects assigned to you, meeting the client’s needs. The role specifically prioritizes, plans, organizes and executes projects related to quality and compliance of health products to ensure smooth implementations. The role may involve coordinating/working with client personnel to meet project goals.
- Reporting to the Manager Quality Services or Manager of Compliance Services, the Lead/Senior Consultant is responsible for:
- Establishing project plans that capture all aspects of the scope of work
- Prioritizing and managing compliance projects
- Completing critical assessments of data and documents to identify gaps compared to regulatory requirements
- Communicating project milestones on a monthly basis
- Completing client assigned tasks: deviation investigations, management of quality systems, review of documentation
- Developing documentation as required by the project: SOPs, protocols, reports, etc.
- Conducting audits both internal and external
- Releasing product to market
- Hosting Health Canada audits
Requirements
- Education - Bachelors' degree in Science required
- Experience in the following is an asset:
- Importation
- Change Management
- Deviation investigations
- Master manufacturing/batch record review and lot release
- Health Canada audit responses Annual Product Quality Reviews
- Stability review and assessment
