Job Description
Review and summarize Annual Product Review and Product Quality Review reports, notify CQLs of issues, and provide summaries for approval. Lead and project manage compliance and continuous improvement initiatives and projects. Support quality tracking and supplier management systems to ensure product compliance. **Key Responsibilities:**
* Review and summarize Annual Product Review and Product Quality Review reports
* Notify CQLs of any issues and provide summaries for approval
* Lead and project manage compliance and continuous improvement initiatives and projects
* Support quality tracking and supplier management systems
* Review and track intercompany complaints and product temperature excursions
* Support product compliance-related activities
**Requirements:**
* University degree in Science, Engineering, Pharmaceutical Sciences or similar
* At least 3 years of Product Quality Assurance experience in a GMP environment
* Aseptic manufacturing experience is an asset
* Experience with external suppliers/contractors is preferred
* Advanced computer skills, including MS Office applications and enterprise systems such as SAP
* Strong verbal and written communication skills, including presentation skills
* Ability to work in a diverse, global environment and report remotely
* Strong negotiation skills and customer focus, with a diplomatic approach to communication