The role of the Quality Systems Specialist (QSS) is to actively contribute to the maintenance of 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 report.
• 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. Contribute 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, track qualification of vendors and periodic risk reviews.
• Maintains Vendor list up to date (including Qualified Vendor List).
• Ensure 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)