Quality Manager at Roche

Job Description
Implement and maintain the Quality System

• Maintain up to date knowledge of the relevant legal requirements and GMP/GDP regulations
• Documentation management – Develop and maintain local procedures, in compliance with the Global Pharmaceutical Quality System Documents
• Perform self-inspections
• Manage Complaints, Recalls and Returns
• Handle Deviations and Investigations
• Training of personnel involved in GxP activities
• Change control
• Manage of local Corrective and Preventive Actions
• Quality Risk Management
• Dealing with internal and external inquiries about the products quality

Ensure an uninterrupted supply of the products to the market

• Release commercial product batches to the local market and Investigation Medicinal Products to the local clinical investigation centers, according to the local regulations, Marketing Authorizations and Clinical Trial Authorizations
• Ensure compliance with GDP guidelines and regulations for the products distributed locally
• Ensure compliance with GMP guidelines and regulations for the products manufactured locally
• Ensure batch traceability for all batches received and distributed by the local warehouse
• Ensure appropriate supervision of the supply chain, and existence of additional controls for the cold chain

Management of GxP out-sourced activities

• Maintain Quality Agreements with local contracted third parties (Warehouse & Distribution, Contracted manufacturer, Contracted Laboratory)
• Perform audits of contracted third parties.

Requirement/Skills

• University degree in one of the following or related scientific disciplines: pharmacy, medicine, veterinary medicine, pharmaceutical chemistry and technology, or biology.