Quality Manager - Roche

Maintenance and continual improvement of the quality system, in order to ensure compliance with the regulations and Roche requirements, and an uninterrupted supply of quality products to the patients.

Key Responsibilities and Tasks

1. 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

2. 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

3. 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

Job Specification – Qualifications, Knowledge, and Experience

Essential

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

Successful candidates will meet the following requirements:

Values are what we value: if you are not accountable, brave and creative, please do not apply;

We believe in servant leadership and we only look for colleagues with the highest level of ethics;