Quality Assurance Lead/Senior Consultant - Importing

This Pharmaceutical Consulting 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. 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 Salary range: CAD 70,000 – 85,000 annually Annual salary will be based on candidate’s experience, skill, knowledge, and qualifications relevant to the role. This posting is for an existing vacancy. 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

The Lead/Senior Consultant is responsible for establishing project plans, prioritizing compliance projects, completing critical assessments of data against regulatory requirements, and communicating project milestones monthly. This role involves executing client-assigned tasks such as deviation investigations, quality system management, and documentation review.

Candidates must be Quality Assurance professionals in the Pharmaceutical industry with 4-7 years of experience, holding a Bachelor's degree in Science. Experience in importation, change management, deviation investigations, master batch record review, lot release, Health Canada audit responses, Annual Product Quality Reviews, and stability review is considered an asset.

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• GMP Knowledge
• Deviation Investigations
• Change Controls
• CAPA
• Auditing
• Quality Systems Management
• Training Delivery
• Batch Document Review
• Product Releases
• Importation Compliance
• Project Planning
• Data Assessment
• Regulatory Requirements
• SOP Development
• Health Canada Audits

• Healthcare
• Consulting
• Management & Leadership
• Science & Research

Formation minimale

Baccalauréat

Expérience minimale

5+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Exigences de lieu

Country, Canada