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Posting id :

55274410

11/24/2022 1:20:22 PM
Quality and Compliance System Consultant
Employer : Tenoryx
 
  City : Brampton Job type :  Career
  Region : ON Hours :  Full-Time
  Country : CA Duration :  Permanent
  Deadline : 3/31/2023
  Education : University or above Experience :  2 to 4 years  
  Salary : $60,000 to $70,000
  Description :  
About Us
Tenoryx Solutions Inc. is a boutique consulting firm located in Canada and serving the global needs of Life Science companies in the Quality, Regulatory, Clinical and IT (Information Technology) space primarily.
Our team of consultants deliver high quality and competitive services primarily for the small to mid-size life science (Biotech and Pharma) companies that are regulated by Health Authorities such as FDA (USA), Health Canada (Canada) and EMEA (European Union). We are highly specialized in providing services such as system implementation and post-implementation support, computer system validation, quality and compliance support, technical writing , GxP training and Data Integrity support.

We are currently looking for a highly motivated and energetic individual to join our team as a Quality and Compliance (Systems Consultant) Consultant.
This role requires the candidate to understand and have experience in the areas of computer system validation and regulatory compliance within the pharmaceutical industry. The candidate will be reporting to a senior consultant to support the projects in the CSV space and ensure deliverables are in compliance with regulatory requirements. An ideal candidate would have experience in implementing cloud solutions for a pharmaceutical manufacturing, clinical or biologics organization
Responsibilities:

• Ensure all CSV activities are compliant with client global and site-specific SOPs & applicable regulatory requirements
• Adopt a risk-based validation approach that focuses the validation effort on high-risk areas of product quality, patient safety and data integrity
• Work with the senior consultant to address deficiencies, deviations, and change controls identified during project execution
• Coordinate and manage project schedules to meet client expecations
• Review and approve documentation for validation activities to support various computer system validation projects
• Stay updated on the various guidance’s associated with data integrity and computer system validation
• Confer with clients to identify and document requirements
• Conduct business and technical studies
• Analyze user's requirements, and design and develop system architecture and specifications
• Design, develop, integrate, test and implement information systems business solutions
• Provide advice on information systems strategy, policy, management, security and service delivery.
• Understanding of Business processes in the Life science and pharmaceutical industry.
• Develop policies, procedures and contingency plans to minimize the effects of security breaches
• Conduct reviews to assess quality assurance practices, software products and information systems
• Propose improvements to methods, systems and procedures
• Collect, organize and maintain a problems and solutions log for use by other technical support analysts
• Stay updated on the various guidance’s associated with data integrity and computer system validation


Qualifications:

• Bachelor’s degree in science, engineering, computer science or other technical discipline
• 3+ years of direct experience in quality assurance and compliance in the pharmaceutical, biopharmaceutical, clinical or medical device industry with a focus on Computer Systems, Computerized Systems and Automated Systems.
• Demonstrate understanding of quality assurance and quality systems principles (training documentation, change control, validation, vendor management and audits)
• Excellent working knowledge in GAMP standards for computerized systems and automated systems and regulatory requirements in data integrity, 21 CFR Part 11 and EU GMP Annex 11.
• Understanding and working knowledge of regulatory requirements (FDA, EU) in validation and qualification standards for pharmaceutical or biopharmaceutical drug product manufacturing for international markets.
• Ability to work in fast paced, challenging environment with limited coaching.
• Demonstrate ability to effectively communicate ideas and actions to all levels of the organization.

Experience & Specialization
• Cloud Systems
• Quality Management
• Regulatory Information Management
• Clinical Trial Management
• VQL
• SQL
• MS Office
• Business process Mapping
• Data Migration

  web site : https://tenoryx.com

  Apply by  
   
   
https://tenoryx.com
Alan Ravindran (Email address: alan.ravindran@tenoryx.com)



 

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