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Quality Management Systems Administrator

August 14 2017
Industries Pharmaceutical, Biotechnology
Categories Information Technology
Laval, QC

Prometic is an established biopharmaceutical company with widely recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule therapeutics development. Prometic offers its bioseparation technologies and expertise for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma to develop and commercialize plasma-derived therapeutics. Prometic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the fields of fibrosis, as well as diabetes, anemia and autoimmune diseases. Headquartered in Laval (Canada), Prometic has R&D facilities in the United Kingdom ("UK"), the United States ("USA") and Canada, manufacturing facilities in the UK and Canada and corporate and business development activities in the UK, Canada, USA and Europe. Prometic's common shares (the "Common Shares") trade on the Toronto Stock Exchange ("TSX") under the symbol "PLI" and the OTCQX International under the symbol "PFSCF".

 

The IT department of Prometic is looking for a QMS Administrator, to work at its location in Laval, Quebec. Under supervision of the IT Director, QMS Administrator plays a critical role in the management of the Quality Management System (QMS). This position interfaces with several departments, including a number of activities, extending from configuration management, document control activities, process development, systems auditing, and database management and technical support/troubleshooting.

 

The mandate of the Computer Systems Validation Specialist will be mainly to:

  • Monitor system performance and availability;
  • Reset passwords;
  • Provide user access support (not covered by a trouble ticket);
  • Work with the help desk to resolve system or access problems (in response to trouble tickets);
  • Create system performance reports;
  • Ensure backup procedures are followed by the Cloud Host;
  • Verify that procedures are followed to ensure regulatory compliance;
  • Assist in the validation tasks associated with the Quality Management System;
  • Under Prometic Change Control Procedures:
    • Maintain User Profiles by adding, removing and editing their permissions;
    • Edit workflows;
    • Create new configurations and editing existing ones;
    • Create new Quality Reports and Graphics and editing or deleting existing reports;
    • Support the impact assessment process for change requests.
  • Follow Prometic's IT Policies and Procedures and ensure Compliance to regulations is maintained (i.e. 21 CFR Part 11, Annex 11, etc.);
  • Other related duties/responsibilities as required or assigned by the supervisor.

 

The selected candidate will preferably hold a Bachelor's degree in Computer Sciences, or in Management Information Systems with 4 to 6 years of related experience, in pharmaceutical and or biotechnology regulated environments. They will have strong knowledge of Quality Management and Document Management systems (e.g., MasterControl, TrackWise), Computer System Validation and System Development Lifecycle (SDLC).

The subsequent competencies would be considered valuable assets: Understanding of regulatory compliance of computer systems (21CFR part 11), statistical analysis and business workflow analysis. Ability to develop clear, concise, and timely reports and accurately complete detailed forms.

 

The following criteria are also required:

  • Excellent written and oral communication skills, in French and English.
  • Strong organizational, problem-solving, and analytical skills.
  • Ability to manage priorities and workflow, handle multiple projects and meet deadlines; Versatility, flexibility and a willingness to work within constantly changing priorities with enthusiasm.
  • Attention to detail.
  • Ability to work independently and as a member of various teams.
  • Commitment to excellence and high standards.

 

Prometic offers a competitive compensation, a flexible work schedule and a casual working environment.

To apply, please send a cover letter and a copy of your resume to **@********.com with the following reference: #PLI-IT-1703. Prometic is an equal opportunity employer. Only chosen candidates will be contacted for an interview.  For more information about Prometic, visit our website www.prometic.com.

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