Quality Assurance Associate

PUB285795

About this role

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.

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).

Requirements

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.

Benefits

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.

Professional woman in office

Join the Brunel Family

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.

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Maria Camanag is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB285795

Account manager

Maria Camanag
Brunel Canada - Toronto
m.camanag@brunel.net

Want similar jobs in your inbox?

Sign up for the Brunel job alert

Look at our privacy statement

Other people also looked at