Quality Assurance Manager
· Responsible for all aspects of Regulatory Affairs and Quality Assurance/Control functions
· Under minimal guidance, critically reviews source documents and prepares and maintains regulatory documents related to Site Licensing, product licencing, SOP’s and represent the lead regarding in house QA and QC daily operations.
· Liaises with internal departments as well as external partners to obtain data required for license maintenance and renewal submissions.
· Compiles regulatory submissions and ensures filings to regulatory agencies are accomplished within established timelines
· Corresponds with Health Canada on a timely basis and ensures that all deadlines are met with regard to renewal of all licenses.
· Maintains all regulatory and quality-related documentation in an organized manner consistent with Health Canada & GMP requirements
· Assists in release of product batches into the Canadian market place
· Leads the preparation for, and facilitates, all client and industry required audits
· Resolves complex regulatory & QA challenges by using appropriate judgement and industry experience.
· Negotiate Quality Agreements with customers and suppliers, as required
· Prepares Deviation/Incident Reports
· Review and approve CAPA for deviation, OOS and audits
· Review and approve Validation and Qualification Protocols and reports including analytical method transfers and validation
· Revise GMP documentation (SOP’s, Forms, etc.) via the change control system
· Updates and maintains the integrity of the QA database
· Maintains current knowledge and awareness of regulatory changes in the NHP and cosmeceutical environment (GMP & Health Canada).
· Ensures that all the work is performed in accordance with SOPs and procedures.
· Ensures that relevant GMP training is provided, recorded and updated for all employees
· Carries out all other duties as assigned.
Application deadline: 2022-02-18
Expected start date: As soon as possible
Job Types: Full-time, Permanent
Pay: $75,000.00 per year
COVID consideration: Fully vaccinated