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Canada
Knight Therapeutics Hiring For Associate, Quality Assurance at Canada 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).
The ideal candidate is highly organised, details oriented, has good communication capabilities, demonstrate good problem solving skills and can adapt to changing priorities.
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.
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..
Candidate Profile
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
