Top Benefits
About the role
Company Description
Accord Healthcare Inc. is a dynamic pharmaceutical company dedicated to ensuring the safety, efficacy, and compliance of drug products. We are currently seeking a dynamic QA Associate to join our team.
Role Description
This is a full-time hybrid role for a Quality Assurance Associate with Accord Healthcare Canada, located in Kirkland, QC, with some work from home flexibility.
Responsibilities :
-
Support product release and manage product life cycle from a Quality perspective for the Canadian market.
-
Ensure compliance with Health Canada’s GMP and regulatory requirements for drug importers/distributors, including establishment licenses, API/FP GMPs, and recall procedures.
-
Maintain and improve the Quality Management System (QMS) including handling change controls (CC), corrective and preventive actions (CAPA), deviations, out of specifications (OOS), investigations, product complaints, and Annual Product Quality Reviews (APQRs).
-
Participate actively in Health Canada GMP and Compliance Audits.
-
Evaluate change controls for product release process and ensure product compliance with the most current approved regulatory dossiers, including product release specifications, master manufacturing & packaging batch records, and process & packaging validation reports.
-
Assess and report on deviations and investigations.
-
C
ollaborate with various departments to maintain compliance.
Qualifications
-
1-2 years of experience in Quality Assurance within a Canadian pharmaceutical company.
-
Knowledge of Canadian GMP requirements as per Health Canada guidance.
-
Knowledge of Quality Management principles.
Understanding of Health Canada’s compliance requirements for importer/distributor establishments.
- Strong organizational and communication skills.
- Ability to work both independently and in a hybrid environment.
Dynamic self-starter and collaborative team player.
- Bachelor's degree in a relevant field such as Chemistry, Biology, or Pharmaceutical Sciences
- Experience in the pharmaceutical industry is a plus.
About Accord Healthcare Canada
Accord Healthcare Inc. is a young and dynamic pharmaceutical company. Operating in Canada since 2009, Accord Healthcare is committed to providing high quality, cost effective generic medicines to Canadian Patients. By being vertically integrated and owning all steps of pharmaceutical development and production process, Accord brings high quality medicines to patients faster, more economically and with greater innovation than our rivals.
In Canada, we have refocused our strategy on oral solid products in order to create better value while supporting the needs of our wholesaler and retail pharmacy partners. Accord Healthcare markets more than 45 oral solid and injectable molecules.
In line with our focus on patient and medicines safety, Accord has introduced a range of Ready-to-Use IV oncology products. The world of pharmaceuticals is changing and Accord is one of the fastest growing companies in the Canadian generic sector. Watch us evolve to meet the challenges of the future.
Accord Healthcare is a wholly owned subsidiary of Intas Pharmaceutical; a vertically integrated global pharmaceutical company specializing in the development and manufacturing of APIs, Generic Medicines and Biopharmaceuticals.
Top Benefits
About the role
Company Description
Accord Healthcare Inc. is a dynamic pharmaceutical company dedicated to ensuring the safety, efficacy, and compliance of drug products. We are currently seeking a dynamic QA Associate to join our team.
Role Description
This is a full-time hybrid role for a Quality Assurance Associate with Accord Healthcare Canada, located in Kirkland, QC, with some work from home flexibility.
Responsibilities :
-
Support product release and manage product life cycle from a Quality perspective for the Canadian market.
-
Ensure compliance with Health Canada’s GMP and regulatory requirements for drug importers/distributors, including establishment licenses, API/FP GMPs, and recall procedures.
-
Maintain and improve the Quality Management System (QMS) including handling change controls (CC), corrective and preventive actions (CAPA), deviations, out of specifications (OOS), investigations, product complaints, and Annual Product Quality Reviews (APQRs).
-
Participate actively in Health Canada GMP and Compliance Audits.
-
Evaluate change controls for product release process and ensure product compliance with the most current approved regulatory dossiers, including product release specifications, master manufacturing & packaging batch records, and process & packaging validation reports.
-
Assess and report on deviations and investigations.
-
C
ollaborate with various departments to maintain compliance.
Qualifications
-
1-2 years of experience in Quality Assurance within a Canadian pharmaceutical company.
-
Knowledge of Canadian GMP requirements as per Health Canada guidance.
-
Knowledge of Quality Management principles.
Understanding of Health Canada’s compliance requirements for importer/distributor establishments.
- Strong organizational and communication skills.
- Ability to work both independently and in a hybrid environment.
Dynamic self-starter and collaborative team player.
- Bachelor's degree in a relevant field such as Chemistry, Biology, or Pharmaceutical Sciences
- Experience in the pharmaceutical industry is a plus.
About Accord Healthcare Canada
Accord Healthcare Inc. is a young and dynamic pharmaceutical company. Operating in Canada since 2009, Accord Healthcare is committed to providing high quality, cost effective generic medicines to Canadian Patients. By being vertically integrated and owning all steps of pharmaceutical development and production process, Accord brings high quality medicines to patients faster, more economically and with greater innovation than our rivals.
In Canada, we have refocused our strategy on oral solid products in order to create better value while supporting the needs of our wholesaler and retail pharmacy partners. Accord Healthcare markets more than 45 oral solid and injectable molecules.
In line with our focus on patient and medicines safety, Accord has introduced a range of Ready-to-Use IV oncology products. The world of pharmaceuticals is changing and Accord is one of the fastest growing companies in the Canadian generic sector. Watch us evolve to meet the challenges of the future.
Accord Healthcare is a wholly owned subsidiary of Intas Pharmaceutical; a vertically integrated global pharmaceutical company specializing in the development and manufacturing of APIs, Generic Medicines and Biopharmaceuticals.