Trackwise Specialist Quality Assurance
Therapure Biopharma Inc. is a biopharmaceutical company focused on complex biological therapeutics and technologies. It is comprised of three divisions: Therapure Biomanufacturing which provides contract development and manufacturing (CDMO) services to global clients; Therapure Innovations, focused on research and development of proprietary therapeutics and platform technologies in the areas of anaemia, liver disease and organ preservation; and Therapure Biologics dedicated to the development of plasma protein therapeutics through an innovative proprietary manufacturing technology.
We are growing! In fact, from 2014 to 2016, we were recognized by Profit 500 as one of Canada’s Fastest Growing Companies.
The position is accountable to address QA activities (QA Software, Microsoft Access, Excel, Word and PowerPoint) as assigned by the Director Quality Operation. The main responsibilities for this position are listed below.
Here is what we are looking for:
- University degree or equivalent with computer science.
- Trackwise user and configuration experience for minimum 3 years.
Here is what you will be responsible for (but not limited to):
- Administration and User Support for Trackwise and all QA electronic Databases
- Design and implement Databases as required by Quality Assurance Managers
- Update and import selection values into Trackwise and Microsoft Access databases as required
- Prepare reports for management review
- Provide training on Trackwise and or other electronic systems as required to new employees
- Liaise with external support system suppliers to resolve technical issues
- Work with internal stake owners and Sparta to implement new modules of Trackwise such as Change control and Audit
- Work with internal stake owners and Sparta to implement new work flows for Incident reporting, Lab Incident Reporting and EM excursion reporting in Trackwise
- Work with internal stake owners and Sparta to improve existing work flows of Deviation investigation, CAPA and CAPA effectiveness module
- Support validation during preparation of URS, protocols, test scripts and execution of validation activities for Trackwise and other electronic database implementation
- Review executed test scripts during validation activities
- Review and update applicable SOP & Manuals for implementation and use of databases
- Co-ordinate and work with New software Vendors, IT (Infotech Department) and Validation for new QA software implementation
- Act as back-up for QA Documentation Coordinator for Paper and electronic documentation Management System
- Act as back-up for electronic learning Management System – Compliance wire
Interested candidates can send their resume and cover letter to firstname.lastname@example.org. Please reference QA Trackwise Specialist in the subject line. While we appreciate all interest in this opportunity, only qualified candidates will be contacted.
Therapure Biopharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure Biopharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure Biopharma Inc. Human Resources team.
NOTE:All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process, applicants are asked to make their needs/requirements known. Please notify Human Resources at HR@therapurebio.com for assistance.