Deviations Specialist-Aseptic Manufacturing Fill Finish
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.
Using aseptic and process knowledge, the Deviation Specialist will be responsible for the investigation of incidents/deviations and along with other Subject Matter Experts and QA Specialists, determine appropriate CAPAs. This, while operating to meet required timelines and within established standard operating procedures that are compliant to Therapure Biopharma Inc., CMO clients, and in accordance with all government regulations.
Here is what we are looking for:
- • A minimum of a B.Sc. or College Diploma in a science discipline
- • A minimum of 5 years of experience writing deviations and performing investigations either in a Production or QA capacity
- • Training in microbiology and/or sterile manufacturing experience is required
- • Experience working with TrackWise will be considered and asset
- • Strong knowledge of GMPs/cGMPs
Here is what you will be responsible for (but not limited to):
- • Investigate incidents/deviations and provide a thorough and complete report
- • Work with Production, Technical Services, other Subject Matter Experts and QA to ensure appropriate CAPAs are determined and put in place
- • Ensure timely completion of investigations for incident/deviation reports and CAPAs
- • Interface with client as required for deviations closure
- • Maintain track of incident/deviations and their associated CAPAs
- • Prepare monthly Deviation Metrics for presentation to senior management
- • Work closely with QA department to ensure all internal and client issues are addressed
- • Perform any other duties as assigned by Manager or Executive Management
Interested candidates can send their resume and cover letter to firstname.lastname@example.org. Please reference the Fill Finish Deviations 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.