Canada, Greater Toronto Area
Fulltime: 37.5 hrs a week
Experience: 2 years
Closing: 14 April 2025

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Introduction

Hiring a Quality Manager who will provide expertise, quality oversight, and guidance on regulatory requirements and best practices for manufacturing equipment qualification, including computerized systems validation. The candidate will support validation strategies, quality processes, and cross-functional project teams, including Bulk Manufacturing, Manufacturing Technology, Engineering, and ITS. A strong technical background, problem-solving skills, and commitment to GMP are essential.

What are you going to do 

  • Provide quality oversight for manufacturing process equipment, CIP, SIP, Thermal, Utilities, HVAC qualification and computerized system validation activities pertaining to B100 licensure, start-up and lifecycle management.
  • Review/approve validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, executed raw data packages, reports, validation plans, SOPs, Equipment registration in SAP) in accordance with internal and regulatory policies.
  • Review, assess and approve change controls, deviations and corrective plans, resulting from validation/qualification studies.
  • As required, represent Quality Operations on project team and/or sub-teams and/or project working groups to provide direction on validation issues with respect to compliance.
  • Responsible for maintaining validation awareness by screening and reporting on significant validation trends and changes through literature reviews, meetings, and peer discussions within the industry.

Essential skills and knowledge 

  • Bachelor's Degree in Engineering / Science or related field
  • 4+ years of experience in a GMP controlled environment/pharmaceutical industry
  • Experience with qualification of manufacturing process equipment is required (examples of manufacturing equipment include: Isolators, Fermentors, Microfiltration and Ultrafiltration systems, Centrifuges, Microplate Readers, etc.)
  • Experience reviewing documentation for completeness, reviewing reports and non-conformances/deviations, administrative tasks and leading meetings.
  • Experience with computerized systems validation is required
  • Validation experience from MSAT or quality side, conducting validation studies 3
  • Biologics or vaccines experience would be a plus
  • Experience with qualification of Delta V, Data Historian OSI PI, and Manufacturing Execution System MES is an asset
  • Technical writing, effective oral and written communication skills, and strong compliance mindset.
  • Good understanding of current and evolving regulatory requirements
  • Strong communication, negotiation, and interpersonal skills and teamwork
  • Good interpersonal and influencing skills are important for a candidate's success
  • Ability to anticipate evolutions due to internal and external factors.
  • Conflict resolution and problem-solving.
  • Familiarity with strategic planning, balanced judgment and risk analysis.

What we offer 

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We'll get you going while you get on with the job.

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.

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Application process

First Contact

We carefully review your application and in the coming weeks, you will be notified for an interview session if you are selected. Only shortlisted candidates will be contacted within 7 days. 
 

Scheduling an Interview

After being shortlisted, you will be contacted via email or telephone to arrange for a date on your availability for the qualification interview. 

Phone/ Qualification Interview

During the interview, you will be assessed on your level of experience and skills, work history, availability, and the qualifications the company is seeking for the position.

Meeting in Real Life

After successfully making through the phone interview, a face to face interview will be scheduled between the candidate and recruiter. This session can be a more in-depth  interview to review your communication and interpersonal skills.

Application for the Position

Submission of candidates resume for client’s approval and screening.

Do you have questions?

SB

Sarah Beaton

+1 403 539 5009

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