Quality Assurance Associate

North York - Ontario - Canada - Life Sciences & Health Care - Pharmaceutical - Regulatory - Academic Bachelor

We’re hiring a Quality Assurance Associate for our client, a global pharmaceutical company, to join their team. This is a 10-month contract opportunity concluding in September 2021.

Feel free to contact

Maria Camanag, Account manager

Apply now

About this role

Responsibilities

  • Assessing the content of regulatory dossiers and comparing the information with operational documents (SOPs, SWIs, BPRs, etc.) and identify potential gaps
  • Categorizing identified gaps in partnership with IA/SQO/Regulatory CMC
  • Liaising with IA, SQO and Regulatory Affairs as required to verify the identified gaps and ensure appropriate documentation of gaps in addition to remediation plans
  • Proposing the gap resolution actions concerning the update of the industrial practices and documentation.
  • Authoring (if appropriate, depending on the organization per site), reviewing and approving the LC documentation including relevant protocols and report(s).

About you

Requirements

  • Bachelor’s degree in life sciences
  • Technical writing experience and the ability to write clear GMP documentation
  • Candidate to be familiar with cGMP requirements (US FDA, Europe and Canada)
  • 1+ years of Quality Assurance experience would be an asset, preferably in biologics
  • Ability to work in a group setting and independently; good teamwork skills
  • Ability to adjust to changing priorities and to manage multiple priorities efficiently
  • Detail orientation is critical for this role, given the required depth of required assessments.
  • Strong interpersonal and communication skills, both verbal and written
  • Strong organizational and time management skills
  • Results oriented
  • Ability to project and maintain a professional and positive attitude
  • Strong planning abilities where potential issues are anticipated and communicated early enough to allow timely resolution
  • Experience working with basic computer software, including MS Word, Excel, and PowerPoint, in addition to Cloud-based platforms, required.

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Publication: PUB285795
  • Location: North York
  • Market: Life Sciences & Health Care
  • Hours per week: 37.5
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of expertise: Regulatory
  • Closing date: Saturday, December 26, 2020
Apply now

Feel free to contact

MC

Maria Camanag

Account manager Brunel Canada - Toronto

+1 416 244 2402

Related vacancies

    Job Alert

    Send me an email with the latest vacancies matching Quality Assurance Associate - Ontario

    Qson is invalid or corrupted You are already subscribed to this Job Alert
    Frequency is not correctly filled in
    Please enter a valid email address
    When creating a Job Alert you agree to our Privacy Statement. You can adjust or cancel your Job Alert at any time.

    Confirmation sent to