Description:
- Maintaining Knight’s Site licences and preparing related amendments and notifications to Health Canada.
- Maintenance of GMP documentation related to Knight’s Site Licence for marketed products according to deadlines.
- Evaluating the lot release of narcotics, pharmaceutical, medical devices and natural health products to the Canadian market.
- Handling marketed product complaints, in collaboration with corporate partners.
- Handling non-conformances received for marketed products, in collaboration with corporate partners.
- Evaluating the manufacturing changes made to marketed products.
- Reviewing APQRs (Annual Product Quality Reviews) for all marketed products.
- Participating in product launch activities to ensure successful market launch.
- Participating to on-site Health Canada GMP audits and, as required, conducting inspections of suppliers involved in the manufacturing and/or distribution of pharmaceutical and natural health products.
- Maintaining and improving internal processes for the development of the Quality Assurance department in collaboration with other Scientific Affairs department.
- Perform other projects/tasks assigned to provide general support to the Quality Assurance Department.
Characteristics of a Good Candidate
- Analytical and Organisational Skills
The candidate must have good analytical skills with high-level attention to detail and commitment to accuracy and depth. She/he will be able to handle multiple projects at a time.
- Negotiation skills / Teamwork
The candidate must have good interpersonal skills and demonstrate flexible and adaptable communications capabilities with partners inside and outside the country, and regulatory authorities. She/he must be able to effectively function in a fast-paced, people oriented, team environment.
- Autonomy / Problem Solving
The candidate must work independently, yet interacting with various people. She/he must have the ability to identify important issues and bring it forward in a timely manner.
- Dealing with Ambiguity
The candidate must demonstrate adaptability in situations involving changes and an ability to evaluate and properly adapt the documents supplied by corporate partners for Canadian regulatory requirements..