Compliance Specialist (f/m/d)

Arbeitsagentur; Penzberg; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Performance-based salary

Up to 30 days vacation

Social benefits incl. bonuses

Career goals defined

Candid corporate culture

Job summary

Roche in Penzberg seeks a Compliance Specialist to support GxP compliance across clinical trial supply management and related activities. The role covers documentation, batch record reviews, TMF filings, and ensuring audit readiness in a dynamic pharmaceutical setting.

The ideal candidate holds a life sciences degree with several years in pharma/biotech, strong GMP/GCP/GDP knowledge, and fluent German and English. A competitive package and extensive social benefits accompany the role.

Qualifications

• 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.

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).

Skills

GxP compliance

GMP knowledge

GCP knowledge

GDP knowledge

MS Office

Quality management

Communication skills

German fluency

English fluency

Regulatory knowledge

Education

Life sciences degree

Tools

QMS software

Job description

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