Job Description

Position Summary The Senior 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:

• Overseeing and corresponding directly with Health Canada to ensure Knight’s Site licences and internal QMS processes are compliant.

• Management of GMP documentation related to Knight’s Site Licence for marketed products according to deadlines.

• Ensuring the lot release of narcotics, pharmaceutical, medical devices and natural health products to the Canadian market.

• Overseeing and handling marketed product complaints, in collaboration with corporate partners.

• Overseeing and handling non-conformances received for marketed products, in collaboration with corporate partners.

• Reviewing the manufacturing changes made to marketed products.

• Reviewing APQRs (Annual Product Quality Reviews) for all marketed products.

• Spearheading product launch QA 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.

• Lead maintenance and improvement 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 3-4 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
• French language proficiency is an asset

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.
If you think you have what it takes, contact us at careers@knighttx.com. 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. A DOUBTFUL KNIGHT RECRUITER COMMUNICATION CAN BE VALIDATED BY EMAILING CAREERS@KNIGHTTX.COM