Quality Documentation Specialist

North York - Ontario - Canada - Life Sciences & Health Care - Pharmaceutical - Project Management & Services - Academic Bachelor

We’re hiring Quality Documentation Specialist for our client, a large pharmaceutical company, to join their team. This is a 1-year contract.

Feel free to contact

Maria Camanag, Account manager

Apply now

About this role

Responsibilities

  • Initiate and manage change control requests affecting the Filling & Packaging department, including presenting change control requests to the change control board.
  • Collaborating with assessors from different functions within IO (quality, Mtech, engineering departments) and outside IO (Regulatory affairs) for evaluation of changes.
  • Ensure timely closure of change controls, including follow up on actions under other departments' responsibility.
  • Develop, revise and perform quality checks on documents and adhere to timelines within the Filling & Packaging department.
  • Follow-up on the review and approval process to expedite document review and approvals when necessary.
  • Work within the policies and regulations as required by the company, regulatory agencies and under the Occupational Health and Safety Act

About you

Requirements

  • 5 years Manufacturing Technology / Quality Operations ideally in Pharma Manufacturing
  • High level of knowledge of cGMP - must understand how to process changes within manufacturing and have the technical knowledge in how to draft, revise, create and approve quality documents in the manufacturing area.
  • Experience in regulatory inspections.
  • Excellent Technical Writing skills.
  • Excellent interpersonal and leadership / teamwork abilities are required - working in a team of 30 people but also interacting with various departments on-site.
  • Knowledge and experience with Quality Systems software, including change control and documentation management systems - experience within a Document Management System/Change Control Quality system.
  • Excellent communication skills for working with a broad spectrum of professional and technical staff and to effectively manage the Change Control requests in an efficient and practical manner.

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 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB228027
  • Location: North York
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Project Management & Services
  • Closing date: Thursday, October 10, 2019
Apply now

Feel free to contact

MC

Maria Camanag

Account manager Brunel Canada Toronto

+1 416 244 2402

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