Quality Assurance Specialist

PUB384684

People in a lab talking

About this job

  • Market: Life Sciences & Health Care
  • Industry: Pharmaceutical
  • Area of expertise: Regulatory
  • Location: Alberta

What is required?

  • Hours per week: 37.5
  • Education level: Professional Bachelor
  • Closing date: Saturday, February 18, 2023

About this role: Quality Assurance Specialist

Introduction

We are currently hiring a Quality Assurance Specialist for our client, a global pharmaceutical company and one of the largest pharmaceutical companies in the world. The company is known for its global contribution in areas including pharmaceuticals and consumer healthcare products. Our client offers the broadest range of vaccines in the world, providing protection against a wide array of bacterial and viral diseases.

Responsibilities

Support Pharmaceutical Quality Systems after project implementation – R&D Quality

  • Continuous Quality Improvement projects for the Pharmaceutical Quality System, specifically documentation flow, review process and SAP transactions for new process for media manufacture outsourced to VIA. The process will be mapped, with clear identification of inputs, outputs, timeline, and roles & responsibilities for all parties involved

    Evolve Quality Systems support model for Plan to Manufacture project implementation, specifically for R&D

  • Update Shop Floor Quality, QTP and Batch Release procedures for clarity, including additional transactional and process steps, for S4/HANA transactions
  • Develop and draft procedures for master data governance for R&D, specifying accountabilities for R&D Quality, VIA, and R&D partners

    Quality Documentation reviews required for projects execution and milestone delivery

  • Executed Media batch record review throughout the term
  • Sterilization record reviews throughout the term
  • Facility cleaning logbook reviews throughout the term
  • Document updates for Operational Quality
  • Gap assessments of procedures against Global Quality Standards

    SAP S4/HANA transactions

  • Master data reviews in SAP
  • Routine operational transactions (e.g., stock posting and usage decisions)
  • Review of master data requests
  • Change control documentation for master data requests
  • Issue resolution and tracking and administration

What you need to bring:

Requirements

  • Strong Quality Assurance background
  • Knowledge/understanding of any Enterprise Resource Planning (ERP) system, preferably SAP
  • Specific knowledge and understanding of Master Data
  • Extensive experience in Quality Documentation review, technical writing (drafting procedures and reports) as well as change control processes
  • Some experience with project management

Benefits:

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.

Anything Else?

Anything Else?

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.

Start applying immediately

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

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

Any questions remaining?

Your consultant, Quynh Vo is happy to clarify anything about this vacancy. When reaching out, use this number:
PUB384684

Account manager

Quynh Vo
Brunel Canada - Calgary
q.vo@brunel.net

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