Associate, Quality Assurance

2 weeks ago

Canada Knight Therapeutics Full time

**Position Summary**
The Associate, Quality Assurance, will assume responsibilities within the Quality Assurance department to ensure the compliance of pharmaceutical products in Canada as well as to maintain Knight quality compliance with Good Manufacturing Practices (GMP) and the company Standard Operating Procedures (SOPs).

This is a full-time Montreal-based position.
**Reports To**
Senior Manager, Regulatory Affairs and Quality Assurance

**The Responsibilities of the Associate, Quality Assurance include**:

- 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.
- **Analytical and Organisational Skills**
- **Negotiation skills / Teamwork**
- **Autonomy / Problem Solving**
- **Dealing with Ambiguity**

**Required**

**Asset**

**Education**:

- B.Sc. in life science discipline or equivalent
- DESS or M.Sc. in drug development or equivalent

**Experience**:

- Strong scientific knowledge
- Excellent communication skills, written and oral in English
- Minimum of 2 years within the pharmaceutical industry in Quality Assurance
- Good knowledge of the Canadian regulations and good ability to interpret policies and guidelines
- Good knowledge of manufacturing processes
- Experience dealing with Health Canada
- Strong command of MS Excel

**Other**:

- Strong knowledge of Microsoft Office Suite

Why Knight?
Are you looking for a dynamic workplace where rapid decision making, entrepreneurial spirit and community are embedded in the DNA? Headquartered in Montreal, Canada, Knight Therapeutics is a fast-growing specialty pharmaceutical company focused on acquiring or licensing innovative pharmaceutical products for the Canadian and select international markets.

**BEWARE OF FAKE RECRUITERS. ONCE RECRUITED, KNIGHT THERAPEUTICS WILL NOT ASK YOU TO BUY YOURSELF YOUR WORK COMPUTER, OR OTHER EXPENSIVE WORK EQUIPMENT, TO BE SUBSEQUENTLY REIMBURSED BY KNIGHT. ALL VALID RECRUITMENT IS ALWAYS DONE BY EMAIL OR PHONE CALLS.**

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