Fill Finish Batch Record Reviewer,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.
Therapure Biopharma Inc. is an integrated biopharmaceutical company that provides contract manufacturing services for the client, development, manufacture, purification, and packaging of therapeutic proteins. The position is accountable to address Production activities as assigned by the Manager, Aseptic Manufacturing and Buffer Preparation relating to clinical and commercial manufacturing and related issues which directly or indirectly impact product quality. The main focus and responsibility of this position is to review Executed Batch Records for accuracy and compliance to GMP.
Here is what we are looking for:
- University degree in Science (Microbiology) with at least a combined 5 years of experience in production (sterile manufacturing) and QA experience.
- Track record of compliance achievements
- Detailed knowledge of GMP guidelines, Health Canada, FDA, EMEA.
Here is what you will be responsible for (but not limited to):
- Review Executed Batch Records including load sheets, equipment print outs, and temperature charts for accuracy and conformance to GMP
- Collaborate with Manufacturing and Quality Assurance groups to resolve product and process related quality issues to bring batch records to closure
- Initiate IR/DR for any process related issues. Work with manufacturing personnel and Compliance Coordinator to bring investigation to closure
- Propose changes to Batch Records to improve process flow and GMP compliance
- Assemble data for Quality Metric Review
Interested candidates can send their resume and cover letter to email@example.com. Please reference Fill Finish Batch Record Reviewer 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.