QA Specialist

PUB331625

medical device pharmaceutical food industry

About this job

  • Industry: Pharmaceutical
  • Area of expertise: Safety
  • Location: Ontario

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor
  • Closing date: Friday, 21 January 2022

About this role: QA Specialist

About this role: QA Specialist

We’re hiring a QA Specialist (Process Team) for a Global and innovative pharmaceutical company on Prince Edward Island. The Quality Assurance Representative, Process Team is responsible to oversee the Quality Assurance responsibilities for the associated process team, to ensure the quality and compliance of veterinary biologics with GMP standards, guidelines set forth by regulatory agencies and company policies.

Responsibilities

  • Responsible to work within and enforce the established quality systems based on the ***** Global Quality Standards and GMP guidelines
  • Provide routine and non-routine quality guidance for the process team functional area, 24/7
  • Provide a daily presence in the manufacturing environment, to:
    • Enable contemporaneous batch record review
    • Provide quality guidance and expertise to production personnel
    • Provide trainings to production personnel and process team on quality related topics
  • Responsible for review and approval of batch documentation
  • Responsible for review and approval of process team quality documents, including but not limited to: SOPs, forms, protocols
  • Function as quality partner, providing guidance to persons creating deviations and change controls impacting the process team functional area; responsible to ensure deviations and change controls meet standards
  • Participate as a lead investigator, deviation approver, and change control assessor for the process team.
  • Maintain a general working knowledge of manufacturing processes in the process team functional area
  • Provide routine trending of process team quality metrics and identify negative trends to enable swift action
  • Quality systems responsibilities.
  • Other duties as required.

Requirements

Requirements

Requirements

  • A Bachelor’s degree in science is required.
  • Training in QA, cGMP or an equivalent quality system.
  • Minimum of 3 years in Quality Assurance and or cGMP facility operation experience
  • Excellent time management and problem-solving skills.
  • Thorough technical understanding of quality systems and regulatory requirements.
  • Experience in root cause analysis.
  • Work effectively in a team environment.

Benefits

Benefits

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.

For more information, please email: r.hamdan@brunel.net

About Brunel

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About Brunel

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How to apply

How to apply

If you meet the above requirements and would like to be considered for this role, please submit your interest using the ‘Apply’ button. Applying is quick and easy – just make sure you have the following documents ready to go:

  • Resume
  • Cover Letter (optional)
Apply now

Do you have questions?

If you have questions or would like to discuss the details of this role, please contact Riham Hamdan via the details below, quoting publication number:
PUB331625

Account manager

Riham Hamdan
Brunel Canada - Toronto
r.hamdan@brunel.net

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