Under supervision of the Quality Assurance Manager
· In accordance with internal SOPs, local and EU legislation, to perform quality activities for our products in support of the QA Experts.
Quality Support & Quality Product Management:
· Providing administrative support for Quality Assurance Team to support high levels of team efficiency.
· Providing QA support to internal Janssen customers and maintaining high levels of internal customer service.
· Product Quality Complaint Reporting
· Performing PQR (Product Quality Review)
· Participation in the Site Master File redaction
Quality Assurance processes & Compliance
· Managing the process for handling non-conformances, including temperature excursions.
· Ensuring all external contractors/suppliers relevant to GMP/GDP are appropriately managed
· Ensuring a robust quality system is in place throughout the supply chain, at third party warehouse and within the company, to ensure compliance with GDP.
· Update SOPs in relation with their activity