Quality Systems Investigator

Winnipeg, MB, Canada

Job Description

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Under the direction of the Supervisor Quality Systems - Investigations, the Quality Systems Investigator is responsible for Complaints, Deviation and related CAPA management. The Quality Systems Investigator must act as a Quality consultant to Operations, being a key point of contact between all departments to promote fitness of the systems and processes employed in their area of responsibility, providing technical oversight and serve as an escalation point where support and intervention is required within the company, to generate reliable, accurate and complete data. The Quality Systems Investigator is expected to possess or obtain sufficient knowledge to provide input or approval of proposed changes to GMP systems during which will interface closely with other cross-functional groups such as Manufacturing, Packaging, Maintenance, Product and Process Development and Warehousing. The Quality Systems Investigator must have an understanding of the Quality requirements as outlined by Regulatory Authorities and apply that understanding to the execution of their responsibilities. Duties will include:
  • Deviation Management:Lead and / or support thorough investigations of identified quality issues ensuring effective corrective and / or preventive actions are identified and implemented in a timely manner.
Assist, support and drive departmental Subject Matter Experts in the completion of deviation actions in a timely manner.Provide assistance and support during investigations with Vendors or Supplier Development and Procurement Management for issues associated with raw materials, contract manufacturing and components.Conduct quality risk assessments following established risk procedures for identifying areas for improvement.Compile and assist with the review of investigation reports for completeness, recommended constructive changes as appropriate.Identify & review the initiation, execution and escalation of related CAPA.Author and review standard operating procedures related to deviation and project management systems.Perform assessments of any given quality system to determine the effectiveness and dependability of such system.
  • Metrics:Participate in and support the maintenance of the Quality Management System and Maintain Quality Department business metrics.
  • Training:Provide on-going training to their department staff as well as other departmental staff as required on deviation and systems management such as the investigative processes and root cause analysis tools to functional areas.
  • Audits:Participate in internal, external as well as Regulatory audits.
Performs other related duties as assigned by Management. Required Experience:
  • Minimum 5 year work experience in the Food, Pharmaceutical or Medical Device Industry.
  • Minimum 3 years working in a GMP regulated environment.
  • Minimum 2 years hands on experience working experience with Quality Systems involved with Document and Deviation management.
Education, Certification, Licenses & Registrations: \xc2\xb7 Bachelor\xe2\x80\x99s in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field preferred. \xc2\xb7 Accredited GMP certification such as ASQ CQE or CQM preferred To be considered for this opportunity, apply here: https://recruiting.ultipro.ca/VIT5000VITH/JobBoard/c331edde-41fd-44ca-a09a-edc53cee1e4a/Opportunity/OpportunityDetail?opportunityId=001c6625-4740-4ca1-9b13-c9d06ce4efd3 Job Types: Full-time, Permanent Salary: $26.00-$29.00 per hour Benefits:
  • Company events
  • Dental care
  • Disability insurance
  • Employee assistance program
  • Extended health care
  • Life insurance
  • On-site parking
  • Paid time off
  • Store discount
  • Vision care
Schedule:
  • Day shift
Application question(s):
  • What is your email address?
  • In order to be considered for this opportunity you need to apply to this link https://recruiting.ultipro.ca/VIT5000VITH/JobBoard/c331edde-41fd-44ca-a09a-edc53cee1e4a/Opportunity/OpportunityDetail?opportunityId=001c6625-4740-4ca1-9b13-c9d06ce4efd3
Education:
  • Bachelor\'s Degree (preferred)
Experience:
  • food, pharmaceutical, or medical device industry: 5 years (preferred)
  • GMP regulated environment: 3 years (preferred)
Work Location: One location

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Job Detail

  • Job Id
    JD2153427
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Winnipeg, MB, Canada
  • Education
    Not mentioned