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Associate, Quality Systems

Contract

Career Connections Canada Inc.

"Connecting great people and great companies"

General Summary:

The main responsibility of this position is to prepare technical reports to support Annual Product Quality Reviews in compliance with company SOP’s, Health Canada and FDA requirements.  This position acts as an active influence towards elevating the quality practices and guidelines for manufactured and packaged product.

 

Principal Duties and Responsibilities:

  • Review compiled data for relevance to product history.
  • Prepare technical reports that assess product attributes and marketing history.  This may include any of the following:

-Raw materials

-Packaging components

-Product specifications

-Method validation

-Master batch records

-Master documentation

-Quality history (Investigations, Change Controls, Rejects, FAR, Recall, CAPA, etc.)

-Product validation

-Equipment

-Executive summaries

  • Compile conclusions and recommendations as they relate to each product.
  • Initiate Change Controls and/or CAPAs as required because of the product quality review.
  • Evaluate previous recommendations and CAPAs in assessing status of currently marketed product.
  • Retrieve data from various sources (BPCS, Change Controls, investigations, rejects, complaints etc.) both electronic and hard copy.
  • Review data and reports for product quality review.
  • Prepare reports and spreadsheets in standardized formats.
  • Provide back up support to QA Stability team- preparation and review of stability summary reports.

Background and Experience:

  • BSc in Chemistry
  • Minimum 2 years of experience with the Pharmaceutical industry combined with knowledge of compliance requirements for the pharmaceutical industry.
  • Strong technical writing ability in a scientific discipline.
  • Ability to analyze data utilizing statistical data software preferred.
  • Somewhat routine problems, infrequent unusual situations
  • Examples are computer application problems.
  • Knowledge/ experience with software applications LIMS and Trackwise preferred
  • Ability to Communicate and work effectively in a team-based environment combined with good written and oral communication skills.
  • Strong organizational and multi-tasking ability to accommodate change in priorities.
  • Proficiency with applicable computer software (Word, Excel) Proficiency with applicable computer software (Word, Excel)
  • Strong organizational and multi-tasking ability to accommodate changes in priorities.

***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc.

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