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:
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:
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.