Quality Specialist

at  Medison Pharma

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.
As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.
Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.
We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people’s lives, we invite you to join us!
The Quality Associate reports to the Senior Manager, QA and is responsible for supporting day-to-day GMP compliance and Establishment licensing activities for Medison Canada.
Please note its a part time position- 3 days a week .

Requirements:

• Bachelor’s Degree in Life Sciences, Pharmacy, Chemistry from a Canadian university or equivalent.
• Thorough knowledge and understanding of Pharmaceutical Quality System requirements, including Good Distribution Practices and Good Manufacturing Practices.
• Post graduate RA/QA certification preferred
• Minimum 5 years work experience in quality assurance in manufacturing or importation/distribution of pharmaceuticals
• Strong written and verbal communication skills
• Detail oriented
• Problem solving ability and innovative strategic thinking
• Commitment to teamwork
• Proficient in the use of Microsoft Office
• Patient and customer focused

Responsibilities:

• Maintain Medison Drug Establishment Licence (DEL), and support filing of DEL amendments. Liase with foreign sites listed on Medison DEL to maintain updated GMP compliance information
• Review and approve manufacturer’s Annual Product Quality Reports (APQRs) and prepare Canadian Addendum, as needed.
• Responsible for batch release of products imported from non-MRA and MRA countries, including biologics.
• Perform Importer quality product annual lifecycle activities such as batch record review and stability reviews
• Initiate, review and approve change controls and deviations as required.
• Oversee supplier qualification program and conduct risk-based evaluations
• Develop, implement and maintain standard operating procedures in accordance with Health Canada regulations and Medison global policies and procedures.
• Manage QMS training program for Medison Canada employees
• Participate in the preparation and execution of external and internal audits.
• Ad-hoc project support, as needed

• Maintain Medison Drug Establishment Licence (DEL), and support filing of DEL amendments. Liase with foreign sites listed on Medison DEL to maintain updated GMP compliance information
• Review and approve manufacturer’s Annual Product Quality Reports (APQRs) and prepare Canadian Addendum, as needed.
• Responsible for batch release of products imported from non-MRA and MRA countries, including biologics.
• Perform Importer quality product annual lifecycle activities such as batch record review and stability reviews
• Initiate, review and approve change controls and deviations as required.
• Oversee supplier qualification program and conduct risk-based evaluations
• Develop, implement and maintain standard operating procedures in accordance with Health Canada regulations and Medison global policies and procedures.
• Manage QMS training program for Medison Canada employees
• Participate in the preparation and execution of external and internal audits.
• Ad-hoc project support, as neede