Specialist, Quality Systems Consultant
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Specialist, Quality Systems Consultant in Toronto, Ontario, CANADA for 12 months CONTRACT, to join one of our major pharmaceutical clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture.
The primary scope of this work is providing training and document management support to identified client organizations.
Major responsibilities:
• Perform all functions of a Document Controller in the trū VAULT electronic document management system, coordinating the life cycle of procedural documents, as required by applicable SOPs
• Manage the review, approvals, periodic reviews, effective dates and obsolescence/retirement of documents in trū VAULT
• Create and maintain training courses, users, user groups and associated curricula
• Deploy/assign training materials and programs to meet organizational needs
• Develop and maintain training plans with designated management from GxP areas
• Collaborate with internal partners to ensure the consistency and efficiency of training curricula and training systems
• Maintain current with training requirements related to any specialized role in the electronic systems used in training and document management (e.g. trū VAULT, Summit)
• Support local business for training deployments and troubleshoot training issues
• Provide guidance to end users for any training and documentation issues
• Generate system reports as requested
• Provide administrative support, documentation/reports for audits/inspections as needed
• This is not an exhaustive listing of job functions. May perform other duties as assigned
Job Knowledge Requirements:
Relevant knowledge and experience
- Bachelor’s degree in a Scientific related discipline
- Minimum 2 years in the Pharmaceutical or Healthcare industry, with Pharmaceutical Quality Systems experience
- Strong aptitude for digital platforms (e.g. Learning Management Systems)
- Expert proficiency in Microsoft Word, Excel, Outlook and PowerPoint
- Excellent interpersonal skills with the ability to collaborate in a team dynamic
- Strong communication skills (verbal, written)
- Superior attention to accuracy and detail with minimal management oversight
- Ability to meet tight deadlines for projects and operational support requests
Core/Technical Competency Requirements
- Demonstrate agility and adaptability in learning new technologies and business processes
- Excellent communication (verbal and written) and strong interpersonal skills
- Demonstrated sound judgment in dealing with risk on compliance matters
- Ability to work independently and in cross-functional team settings
- Manage multiple priorities including owning and balancing project management in conjunction with daily work
- Ability to work and collaborate within a matrix environment
- Strong analytical thinking with excellent data collection, analysis and problem-solving skills
- Proficient in Document and Learning Management tools, preferably trū VAULT and Summit
- Time Management & Focus, Project Management skills
ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.
We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA"), personal information is collected under the authority of the Act and will only be used for candidate selection.
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