Quality Systems Specialist/ Spécialiste des Systèmes de Qualité

The role of the Quality Systems Specialist (QSS) is to actively contribute to the maintenance of a compliant quality system. The QSS also conducts internal audits and can assist in regulatory inspections and client audits. Additional activities in the sector of computerized systems and IP release can be assigned based on role and qualification.

More specifically, the Quality Systems Specialist must:

• Executes audits in accordance with the established audit program.
• Performs audit activities such as planning, conducting, and writing of audit reports.
• Issues observation/recommendations and reviews appropriateness of responses/CAPA plan. Follow up on CAPA plan until closure.
• Reviews the NCs related to quality systems and tracks trends and progress of CAPA closing. Contributes to activities related to quality indicators.
• Contributes to consultation on quality systems related issues. Can participate in process improvement initiatives.
• Contributes to training content related to quality systems and GxP topics. Can provide training to Innovaderm employees.
• Completes RFI requested by clients. Can assist in client qualification audits and regulatory inspections including mock inspection activities.
• Contributes to the writing/revision of quality documents.
  
  

Employees may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified, and/or have received adequate training.

Specialty: Vendor Management

• Performs review of vendors RFI, tracks qualification of vendors and periodic risk reviews.
• Maintains Vendor list up to date (including Qualified Vendor List).
• Ensures proper investigation and CAPA plan has been established for Vendor Finding.
• Works closely with the Vendor Management Organization (VMO) at Innovaderm.
  
  

Other task(s):

• Perform release of IP (GMP background required)
  
  

Requirements:

• Bachelor degree in a relevant discipline or equivalent experience;
• Minimum of 3 years’ experience in quality assurance in the pharmaceutical industry or clinical research;
• Good knowledge of ICH guidelines and applicable regulations (Health Canada, FDA, EU);
• Ability to communicate effectively both orally and in writing;
• Good knowledge of good clinical practices, and applicable GxP regulations Health Canada and Food and Drug Administration (FDA) and EU regulations;
• Knowledge of GMP (an asset);
• Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint);
• Knowledge of artificial intelligence applications is an asset (e.g., Copilot);
• Good organization skills and ability to adapt to a rapidly growing environment;
• Bilingual: French and English, written and spoken;
• Willing to travel 10-30% of the time;
• Experience in clinical quality and dermatology/rheumatology (an asset).
  
  

Our company:

The work environment

At Innovaderm, you will work with brilliant and driven colleagues. Our values are integrity, commitment, and teamwork. We offer a stimulating work environment and attractive advancement opportunities.

As a Quality Systems Specialist, you will be eligible for the following perks:

• Flexible work schedule;
• Permanent full-time position;
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities);
• Ongoing learning and development.
  
  

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology with a team of over 350 employees. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America.

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

We thank you for your application and please note that only those selected for an interview will be contacted.

Innovaderm only accepts applicants with a work permit for Canada.