ITOT Compliance Engineer (Advanced Expert CSV)
Are you a highly skilled and experienced engineer with a passion for compliance in the pharmaceutical industry? Do you have a strong background in computer systems validation (CSV) and a deep understanding of ITOT (Information Technology/Operational Technology) compliance requirements? If so, we have an exciting opportunity for you at Roche as our ITOT Compliance Engineer (Advanced Expert CSV).As the world's leading biotech company, Roche is dedicated to improving the lives of patients through innovative medicines and diagnostic tests. As our ITOT Compliance Engineer, you will play a critical role in ensuring the quality and compliance of our computer systems and technology infrastructure, enabling us to continue delivering life-changing treatments to patients around the world.We are seeking a highly qualified individual with a strong understanding of CSV principles and regulations, as well as experience in implementing ITOT compliance strategies. Our ideal candidate is a self-motivated and detail-oriented professional with excellent communication and problem-solving skills.If you are ready to take on a challenging and rewarding role in a dynamic and innovative company, we encourage you to apply for our ITOT Compliance Engineer position at Roche. Join us in making a difference in the lives of patients worldwide.
- Develop and implement ITOT (Information Technology/Operational Technology) compliance strategies to ensure Roche's computer systems and technology infrastructure meet all relevant regulations and standards.
- Conduct thorough and ongoing evaluations of Roche's computer systems to ensure compliance with CSV principles and regulations.
- Collaborate with cross-functional teams to identify and address any compliance issues or gaps in Roche's ITOT systems and processes.
- Monitor and track changes in regulatory requirements and industry best practices related to ITOT compliance, and provide recommendations for updates to Roche's processes and procedures.
- Lead the validation of new ITOT systems and modifications to existing systems, ensuring they meet Roche's quality and compliance standards.
- Develop and maintain comprehensive documentation for all ITOT systems and processes, including validation plans, protocols, and reports.
- Conduct training and awareness programs for Roche employees on ITOT compliance requirements and best practices.
- Investigate and resolve any ITOT compliance deviations or issues, and implement corrective and preventive actions to prevent future occurrences.
- Act as a subject matter expert on ITOT compliance for Roche, providing guidance and support to internal teams and external stakeholders.
- Continuously monitor and improve Roche's ITOT compliance processes and systems to ensure they are efficient, effective, and in line with industry standards.
- Stay up-to-date on emerging technologies and trends in the pharmaceutical industry and ITOT compliance to inform and improve Roche's compliance strategies.
- Collaborate with external partners and vendors to ensure their ITOT systems and processes meet Roche's compliance requirements.
- Participate in audits and inspections by regulatory agencies and respond to any findings related to ITOT compliance.
- Communicate regularly with management and stakeholders on the status of ITOT compliance and any potential risks or issues.
- Mentor and provide guidance to junior team members to develop their skills and knowledge in ITOT compliance.
Extensive Knowledge Of Computer System Validation (Csv) Regulations And Industry Standards Such As Fda 21 Cfr Part 11, Eu Annex 11, And Gamp 5.
Expertise In Developing And Executing Csv Strategies And Protocols For Complex It And Ot Systems, Including Hardware, Software, And Network Infrastructure.
In-Depth Understanding Of Operational Technology (Ot) Systems, Including Industrial Control Systems (Ics), Building Automation Systems (Bas), And Data Acquisition Systems (Das).
Experience With Risk Assessment Methodologies, Including Fmea And Fta, And The Ability To Identify And Mitigate Risks Associated With It And Ot Systems.
Strong Project Management Skills, Including The Ability To Lead Cross-Functional Teams, Develop Project Plans, And Manage Timelines And Budgets.
Risk Management
Quality Assurance
Project Management
Change control
Regulatory compliance
Documentation management
Data Integrity
SOP Development
Audit Readiness
Gxp Regulations
Computer System Validation
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a ITOT Compliance Engineer (Advanced Expert CSV) in 82377 Penzberg, Germany is €60,000-€80,000 per year. However, this can vary based on factors such as level of experience, specific job duties, and the company's industry and size.
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Roche Holding AG operates as a research healthcare company. It operates through the diagnostics and pharmaceuticals segments. The pharmaceutical segment refers to development of medicines in the field of oncology, immunology, ophthalmology, infectious diseases and neuroscience. The diagnostic segment refers to diagnosis of diseases through an in vitro diagnostics process.
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