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Quality Services Associate

Hamilton, Ontario
Permanent
Reference: 061155_1571232527
Description

Quality Services Associate

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

We are looking for passionate, resilient, and inspiring individuals to join our team. As a Quality Services Associate is a supportive role for clients, agency and client inspections, SOPs, quality agreements, product disposition pre and post-market. You will ensure adherence to current GMPs and can be called on for Natural Health Products as well as Pharmaceutical Drugs.

The role

  • Review batch records supports complaints and deviations
  • Performs return product disposition
  • Maintains a positive and productive liaison with internal and external contacts. This may include clients, regulatory agencies, and related institutions
  • Attend formal interactions (face to face meetings, teleconferences, etc) with clients and possible government agencies
  • Perform Annual Product Quality Reviews
  • Supports request of Certificate of Pharmaceutical Products
  • Maintain current GMP knowledge
  • What you need

  • Minimum of a life sciences degree (BSc, MSc)
  • Comprehensive experience in Quality including knowledge of current GMP in Canada, US and Europe. Good working knowledge of ICH, US and Canadian legislation and regulatory guidance
  • Strong computer skills
  • Ability to build positive, productive relationships with colleagues and clients
  • Advanced level in written English, Intermediate level in oral English. Ability to speak and write in French is an asset
  • Why join us?

    Ongoing development is vital to us, and as a Study Support Assistant you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

    ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

    EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin

    #LI-SB1

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