Junior Quality Assurance / Document Specialist

Etobicoke - Aargau - Canada - Life Sciences & Health Care - Pharmaceutical - Regulatory - Academic Bachelor

We’re hiring a Junior Quality Assurance/Document Specialist for our client, a large pharmaceutical company, to join their team. This is a permanent position.

Feel free to contact

Diana Grodowski, Account manager

Apply now

About this role

Responsibilities

  • Assist with management and organization of laboratory documentation.
  • Issue controlled forms and maintain document control.
  • Perform vendor qualifications following established procedures.
  • Revise SOPs for clarity and to ensure accuracy with current practice and regulatory requirements.
  • Ensure changes to the Quality Systems are documented through change control procedures.
  • Initiate CAPA’s resulting from deviations, identified non- conformances, and audit observations.
  • Prepare and file deviation reports and assist with the documentation of OOS investigations.
  • Assist with responses to external, internal and audit observations.
  • Assist with qualification (IQ, OQ, PQ) and verification of instruments; ensure all equipment is maintained and within calibration.
  • Conduct data review prior to issuing Certificates of Testing, Analytical Reports and Study Reports.
  • Perform data restoration checks to verify the completeness/accuracy of the backup data.
  • Maintain up-to-date inventories of all temperature-controlled units.
  • Liaise with other lab personnel, scientists, suppliers, clients/customers about quality-related matters.
  • Candidate will be working in an office and GMP-compliant, biosafety level 2 laboratory environment.
  • Assist with general lab and housekeeping routines
  • Assist with the validation of Excel spreadsheets.

About you

Requirements

  • A minimum of a BSc in biological sciences.
  • A minimum of two years’ experience as a laboratory technician/technologist or pharmaceutical quality assurance associate.
  • A proven ability to be highly productive and successful in a high pace work environment with excellent attention to details.
  • Competency in computer skills and familiarity with Microsoft Office programs.
  • Working knowledge of FDA, ICH and Health Canada guidelines and regulations pertaining to pharmaceutical GMPs.
  • Excellent interpersonal, verbal and written communication skills.
  • Self-motivated and comfortable working in a fast-paced environment.
  • Excellent team player.
  • Willing to accept additional responsibilities outside of initial job description.

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: PUB227159
  • Location: Etobicoke
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Regulatory
  • Closing date: Friday, October 4, 2019
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada Toronto

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