Quality Assurance Specialist (GCP Auditor)
Innovaderm
Montreal, Canada
1d ago

In collaboration with the 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, QA metrics, client audits and regulatory inspection.

RESPONSABILITIES

More specifically, the QA Specialist will :

  • 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.
  • PROFILE

  • Bachelor degree in a relevant discipline or equivalent experience;
  • 3 to 5 years’ experience in quality assurance in the pharmaceutical industry or clinical research;
  • 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);
  • Willing to travel from 10 to 20%;
  • Experience in clinical quality assurance and dermatology is an asset.
  • The work environment

    At Innovaderm, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.

    As a QA Specialist, 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)
  • Ongoing learning and development
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