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Quality Assurance Specialist (GCP Auditor)


In collaboration with the Senior Director, Quality Assurance, the Quality Assurance Specialist manages the planning, execution and follow-up of GxP audits (systems, vendors and clinical sites). The QA specialist may also have to provide support to the Quality Assurance (QA) department in other areas, such as activities related to SOPs, training, computerized system validation, QA metrics, client audits and regulatory inspection.

 

This role will be perfect for you if:

  • You approach challenges with an understanding of norms and regulations, combined with a creative and inquisitive mind.
  • You enjoy working with a small team, contributing your experience and expertise to complete a variety of tasks , including special projects.

 

 

RESPONSIBILITIES

  • Coordinate, plan and conduct audits (internal and external) as per annual audit plan;
  • Ensure that corrective and preventive actions are addressed in a timely manner following internal audits, client audits and regulatory inspections;
  • In collaboration with CRO Operations, participate in quality management of vendors (initial qualification and routine audits);
  • Participate to the development of training content related to Good Clinical Practices, Good Documentation Practices and any other quality-related matter in the conduct of clinical trials;
  • Participate to the activities relating to client audits and regulatory agencies inspections such as preparation, conduct and follow-ups;
  • Support the QA department in its activities.

 

 

IDEAL PROFILE

 

 

Education 

  • Bachelor degree in a relevant discipline or equivalent experience;

 

 

Experience 

  • 3 to 5 years’ experience in quality assurance in the clinical research industry;
  • Experience in clinical quality assurance, in computerized systems validation and dermatology is an asset.

 

Knowledge and skills

  • Good knowledge of ICH guidelines, FDA and Health Canada regulations;
  • Master the overall audit process including a systems-oriented approach
  • Ability to write audit reports and identify major and critical issues and to communicate effectively both orally and in writing;
  • Ability to adapt to a rapidly growing environment;
  • Bilingual: French and English, written and spoken;
  • Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint);
  • Experience in clinical quality assurance and dermatology is an asset.

 

 

OUR COMPANY

 

The work environment

 

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

 

In this position, you will be eligible for the following perks: 

  • Flexible work schedule
  • Permanent full-time position
  • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
  • Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
  • Possibility of working from home in accordance with company policies and public health directives
  • Ongoing learning and development

 

 

About Innovaderm

 

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

 

 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

 

Innovaderm only accepts applicants who can legally work in Canada.

 

 

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