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Quality Assurance Coordinator

June 8 2017
Industries Pharmaceutical, Biotechnology
Categories Administrative Support, Research and development, Scientific and Regulatory affairs
Montreal, QC

In relevant with the Quality Officer, the coordinator ensures compliance with regulations and internal standards, maintains and improves Innovaderm's quality assurance systems and, provides support during client's audits and inspections. 

Your responsibilities

Contributes to the improvement of quality assurance processes at Innovaderm.

More specifically, the Quality Assurance Coordinator :

Quality Documents Administration

  • Regularly reviews and updates the quality documents lists based on the quality documents status;
  • Coordinates the review and approval of the quality documents within the prescribed time frame;
  • Performs QC review of all new and revised quality documents received from authors to ensure that the format meets internal standards, that the content is clear, logical and that SOPs comply with the language of other SOPs internally;
  • Manages the updating, finalization and distribution of quality documents for training;
  • Reviews the quality documents matrix based on the corporate organizational chart and updates the matrix as required;
  • Manages the archiving and uploading of quality assurance documents (written and electronic versions) according to established standards.

Training Administration

  • Administers eLearning systems;
  • Ensures proper assignment of training in the training systems;
  • Maintains training documentation.

Audits and Inspection

  • Supports client audits and inspections at Innovaderm;
  • Ensures the completeness of clients' audit, inspection and audits conducted by Innovaderm;
  • Ensures the maintenance of documents related to quality assurance (e.g., inspection readiness) at all times in an orderly manner and in compliance with the relevant SOP standard.

Vendor Management

  • Ensures all required vendor documentation is maintained;
  • Ensures the vendor tracking lists are up-to-date.

Support Quality Officer

  • In collaboration with the Quality Officer, prepares quarterly reports on non-conformities and CAPAs.
  • In the absence of the Quality Officer, serves as the first contact for internal administrative issues related to quality assurance.


Requirements

  • College Degree (DEC) ;
  • Experience in Quality Assurance, clinical research or regulatory affairs;
  • Good knowledge of GCP and ICH, FDA and applicable regulations;
  • Excellent knowledge of the Microsoft Office suite (Word, Excel and PowerPoint);
  • Excellent ability with computerized systems;
  • Bilingual: French and English, written and spoken;
  • Minimum 2 years of experience in pharmaceutical / medical devices industry;
  • Detailed oriented, autonomous and rigorous;
  • Strong ability to manage and prioritize different assignments, work under pressure and meet timelines. 


Thank you for your application and please note that only selected candidate will be contacted.

The masculine gender designates both sexes with no discrimination intended, and is used only to facilitate reading

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