Teva Canada

Quality Assurance Auditor

CA-ON-Markham
2 months ago
Job ID
17-19402
# Positions
1
Category
Quality - Quality Assurance

Overview

Position Snapshot

The Quality Assurance Auditor will provide support to operations by performing reviews of manufacturing/packaging documentation and performing timely releases of bulk/printed packaging components. In addition to performing daily walkthroughs, review of log books and facilitate with quality incidents as required. The Quality Assurance Auditor will report to the Quality Assurance Supervisor in Markham.

Responsibilities

  • Audit executed commercial, validation & technical services packaging batch records ensuring GMP and SOP compliance. Also, perform audit, retest and release of printed packaging components. Complete QA final ID sample, prepare accurate, clear and logical audit notices and maintain auditing metrics.
  • Use of Oracle, CMMS, cME, TrackWise, Knowledge Tree and LIMS in order to verify, retrieve, enter and/or process relevant information such as expiry/retest/manufacturing start dates, average weights, batch/analytical testing status, work orders, Deviation Reports, change controls, tracking auditing metrics etc
  • Ensure all records (batch records, investigation reports, etc.) are properly and adequately maintained and filed appropriately in accordance with approved Teva Canada procedure to ensure audit readiness for regulatory and customer audits
  • Capable to perform AQL evaluations including verification and evaluation.
  • Review and ensure that appropriate actions and conclusions are included for all entries on the product summary sheet.
  • Co-ordinate with the Quality Assurance, Planning Department, and QC on status of batch documentation audits to facilitate timely product release.
  • Work collaboratively with site operations/QA in the resolution of GDP/GMP deviations to ensure compliance with GMPs and SOPs. Respond to quality incidents as required
  • Assist in the sampling and tagging of raw materials, packaging components or bulk & finished products.
  • Other duties as assigned.

Qualifications

Candidate Profile:

You have a proven track record of accuracy in your work. You can multi task and determine priorities.   You are able to make recommendations and influence others to be Quality champions.

You are a strong team player and able to communicate with various levels in the organization.

You will excel in this role if you have strong written and verbal communication skills and you are able to work independently.

 Selection Criteria

  • College Diploma in Science or related discipline. University degree in a Science discipline is preferred.
  • One (1) year relevant experience in Quality Control, Quality Assurance, Product Development or Production.
  • Proficiency with computer systems, specifically demonstrated knowledge of Oracle, Trackwise, LIMS and/or cMe/SQA.
  • Highly motivated individual with initiative and strong attention to detail.
  • Strong time management and organizational skills.
  • Good working knowledge of SOPs, GMPs, and cGMP’s applicable to Quality Operations, Manufacturing and Packaging
  • Excellent interpersonal skills, professional attitude, with the ability to produce consistently high quality work.

 

  • Strong problem solving and analytical abilities.

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