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Quality Director / Quality Management Representative (QMR)

Req # JR - 017373 Location Alliston, Ontario, Canada Job Category Quality Control Date posted 06/17/2020

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SUMMARY OF RESPONSIBILITIES

Manage the activities of the Quality Management function in a manufacturing environment in order to provide products, services and systems, which meet the required standards of quality, safety and value.


ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Direct the Q.M. function to ensure that all products & services comply with Regulatory & Baxter requirements. Manage all issues regarding compliance, product acceptability, risk assessment and function operation. Translate and implement Baxter Business/Quality Standards into measurable objectives for Alliston.

  • Review, analyze and evaluate the Quality Management, Plant Quality systems through exception management; data trend analysis, routine internal audits, and other risk management tools to prevent potential risk of product quality and to minimize legal and regulatory concerns for the corporation. Summarize and present Quality Reviews and ensure actions are taken to address specific trends.

  • Facilitate and assure implementation of new product/process continuous improvements through interface with other functions both locally and with corporate and regulatory representatives. Implement Lean/Business Excellence principles (collectively Baxter’s Enterprise Management System) to drive continuous improvement in key areas of the Quality Systems and support business/operational objectives.

  • Act as the Management Representative for maintaining compliance to the Baxter Corporation Quality Manual and ISO9001, ISO13485, and applicable MOH requirements. Deal directly with Health Canada and other MOH’s on plant audits, compliant investigations and Process Parameter Release.  Deal directly with customer, Corporate and ISO and MOH representatives on plant audits and follow-up.

  • Participate in the evaluation and documentation of product complaint data and implement product/process improvement changes as necessary.Coordinate the activities of the complaint handling/corrective actions teams.

  • Ensure that products are released in a timely manner such that a constant supply is available to our customers.Create, approve and manage annual budget for the QM function. Manage the methods and rationale of product physical testing and sourcing of supplies to streamline and reduce costs.Determine long term strategies for capital expense requirements. Establish processes to prioritize use of resources.

JOB REQUIREMENTS

  • B.Sc in Chemistry, Microbiology, or Pharmacy
  • Quality Assurance, Pharmacy Quality Systems, Management Experience
  • Min. 10 years within Quality Systems, 5 years in a Quality Management Position within a healthcare (regulated) environment

Additional Skills / Special Training / Technical Skills Required


Required:

  • Quality System,
  • Statistics
  • Scientific Method
  • Sterilization
  • Management Experience


Preferred:

  •  Manufacturing experience in Pharmaceutical company
  •  Lean
  • Analytical and/or Micro experience


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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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