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
If you are a Quality Assurance professional in the Pharmaceutical industry with at least 4-7 years experience, we have the environment and exposure to the type of work you want to do.
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
Benefits
Learn about what makes our company unique at www.qualityandcompliance.com.
Q&C welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process
Top Skills
What We Do
Q&C is the largest independent full-service consultant and importer for Health Canada, US FDA and internationally regulated drugs, APIs, natural health products and medical devices. We bring over 25 years of experience to our clients, providing expert consulting on regulatory and compliance matters, including industry best practices, assistance passing inspections and audits, and authoritative guidance for drug importation into Canada.
We wrote the book on compliance. Over 200,000 copies of our authoritative, cross-indexed and pocket sized Blue Book™ have been published. A commitment to quality is at the core of everything we do and is backed by our Health Canada licenses and ISO registration.
Q&C tailors our services to deliver the most efficient and cost-effective approach to your project. Up to 70% of our business is repeat, because we deliver results. From large, multi-faceted quality initiatives to the most specialized tasks, including Health Canada remediation, data integrity, product and facility licence submissions, backlog cleanups and interim quality services, we bring deep expertise, complimentary skill sets, and built in back-up to every assignment.
We also bring project management expertise that ensures that your project moves smoothly, you are well informed at every stage, and your needs are met.
Q&C also holds a Drug Establishment Licence (DEL), Natural Health Product Site Licence (SL) and Medical Device Establishment Licence (MDEL), and acts as the Health Canada licensed importer for over 250 products.
With our 25+ years of experience handling the importation of Health Canada regulated products, we are known for the results we deliver. Our Quality Department and Rapid Release Team™ ensure complete compliance and make it faster and simpler to get your product to the Canadian marketplace.
For more information about our people, our services, and recent projects, visit www.qualityandcompliance.com. For careers, please visit http://bit.ly/2p
