Lead/Senior Consultant - Importing (Pharma)

The Quality Assurance Specialist - Pharmaceutical role is a "Lead or Senior Consultant" position at Q&C. 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. Depending on your experience and career goals, the successful candidate would be placed in one of the two operational companies : Q&C Services - focuses on supporting importing projects where importing experience is an asset OR QCR - supports various quality consulting roles.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.ResponsibilitiesReporting 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 workPrioritizing and managing compliance projectsCompleting critical assessments of data and documents to identify gaps compared to regulatory requirementsCommunicating project milestones on a monthly basisCompleting client assigned tasks: deviation investigations, management of quality systems, review of documentationDeveloping documentation as required by the project: SOPs, protocols, reports, etc.Conducting audits both internal and externalReleasing product to marketHosting Health Canada auditsIf 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.QualificationsExperience in the following is required -Importation experience (would be an asset)Change ManagementDeviation investigationsMaster manufacturing/batch record review and lot releaseHealth Canada audit responses Annual Product Quality ReviewsStability review and assessmentBenefitsLearn 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

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