supplier qualification quality assurance

advertisement
SUPPLIER QUALIFICATION
QUALITY ASSURANCE
About Us
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, in 2014 & 2015, we were recognized by Profit 500 as one of
Canada’s Fastest Growing Companies.
The position is accountable to address Vendor Qualification and management of vendor files
as required by Quality Assurance Manager – Compliance relating to clinical and commercial
manufacturing batches for Raw material, Packaging Material and product contact materials
that directly or indirectly impact product quality. The main focus and responsibility of this
position is to provide management of Vendor Qualification systems which directly impact the
regulatory compliance status of the company. This Job requires 25-30 % travel both national
and international.
Here is what we are looking for:
 Bachelor degree in related science
 5 or more years of QA experience.
 Pharmaceutical Vendor/ Supplier qualification experience
 ASQ certification and auditing experience
Here is what you will be responsible for (but not limited to):
 Approve vendors and maintain database
 Approve materials and maintain Data base
 Work on new material requests
 Review in coming material specifications for QA Manager approval
 File incoming material specifications and COAs
 Maintain Supplier files and perform annual risk assessment.
 Perform Vendor Audits
 Prepare vendor audit reports and follow-up CAPA
 Review and approve work orders and MCCP
 Executed PM documents review and approval
 Provide proactive role in moving quality & compliance goals forward throughout the
organization and achieving positive and value added results
 Work closely with purchasing department to assist them in implementing effective, risk
based GMP processes, Vendor assessment and qualification.
 Performs additional duties as required.
Interested candidates can send their resume and cover letter to talent@therapurebio.com.
Please reference the SUPPLIER QUALIFICATION 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.
SUPPLIER QUALIFICATION
QUALITY ASSURANCE
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.
Key Words: pharmaceutical, therapure, biopharma, specialist, vendor qualification, supplier
qualification, quality assurance
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.
Download