Compliance Specialist (f/m/d) in Penzberg

We have a vacant position as compliance specialist at the pharmaceutical company Roche in Penzberg. Tariff-based wages, care by a company medical center, and employee discounts are advantages that you can count on with Randstad. Applications from individuals with disabilities are warmly welcome.

Responsibilities

• Support GxP compliance of all activities in the clinical trial supply management, drug-related distribution and storage
• Responsibility for the project-related GxP documentation and maintenance of lists
• Operational support and independent performance of operational tasks as process expert in the IMP GxP Compliance Team across diverse clinical trials and R&D Programs (e.g. Batch Record Reviews and TMF Filing)
• Establish and maintain inspection readiness for clinical trial supply activities and support in preparing, accompanying and following up on audits and inspections
• Optimization of processes and workflows (e.g. support in the creation and review of SOPs and other GxP related documents)

Requirements

• Completed university degree or a similar education with a scientific focus
• Several years of work experience in the pharmaceutical or biotech industry
• Knowledge of quality standards (GMP, GCP, GDP) and regulatory requirements in an international environment
• Profound skills in the use of MS Office applications and a quality management system
• Strong communications skills, good German language skills and fluency in English

Benefits

• Performance-based salary package depending on qualifications and professional experience
• Up to 30 days vacation per year
• Extensive social benefits, incl. Christmas and holiday bonuses
• Definition of career goals
• Candid corporate culture

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