Compliance Coordinator 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.
The focus of this role is to assist the department management with achieving and maintaining a high level of GMP compliance within the department in order to meet client, Regulatory Agency and Therapure requirements.
Here is what we are looking for:
- University Degree or College Diploma in a science discipline.
- 1-3 years of Pharmaceutical experience
- Ability to create/edit SOPs and BPRs
- Strong working knowledge GMP is ideal
- Knowledge of GMP guidelines, Health Canada, FDA, EMEA is an asset
Here is what you will be responsible for (but not limited to):
- Initiate Incident Reports (IR) based on initial information available/provided and gather additional information (copies of Log books, BPRs, interview etc.) and ensure they are submitted to QA on a timely basis
- Initiate Change Controls (CR), based on instructions from Subject Matter Experts (SME) or from Corrective Actions/ Preventive Actions (CAPA):
- make red-lines on SOPs and BPRs based on CRs
- route and obtain approvals from appropriate departments
- ensure timely closure
- Provide log book data to Microbiology for EM excursion investigations
- Provide proactive leadership in moving quality & compliance goals forward within the department
- Assist with gathering documentation required to obtain batch records from QA
- Assist with audit preparation
- Work closely with department staff to assist them in implementing effective, risk based GMP processes, procedures and documentation.
- Perform additional duties as required.
Interested candidates can send their resume and cover letter to firstname.lastname@example.org. Please reference Fill Finish Compliance Coordinator 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.