Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our
Project Services
Senior Consultant Computer System Validation and IT Compliance
- Lead and oversee computer system validation (CSV) efforts for life sciences clients, ensuring adherence to regulatory requirements such as 21 CFR Part 11 and 21 CFR Part 820, but not limited.
- Develop and implement comprehensive lifecycle documentation for GxP relevant computer systems, including the creation and execution of test protocols.
- Review technical documentation and support IT compliance strategies to maintain the security, reliability, and regulatory compliance of computer systems.
- Collaborate with cross-functional teams, including IT, Quality, and Regulatory, to design and execute validation plans for both new and existing computer systems and digital initiatives.
- Provide expert guidance and support on CSV and automation testing, ensuring best practices and regulatory compliance.
- Experienced in DevOps, Agile, Scrum, Waterfall, and ITIL methodologies, with a strong understanding of industry best practices.
1
- Bachelor’s or master’s degree in computer science, Engineering, Pharmaceuticals, or a related field.
- Minimum of 4 years of experience in computer system validation (CSV), hardware qualification, IT compliance, testing automation, or related disciplines.
- In-depth knowledge of relevant regulations and industry best practices, including FDA regulations, EudraLex and GAMP5.
- Proven ability to lead and manage multiple CSV projects and digital initiatives, including documentation development, testing efforts, and compliance assurance.
- Experience with testing automation tools, process-controlled systems, application lifecycle management tools and paper-based testing
- Strong communication skills with the ability to work effectively with cross-functional teams
- Expertise in cloud-based solutions, SAP, Clinical Trial Management Systems (CTMS), Veeva Vault, Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), electronic Lab Notebooks (eLN), change management, deviation and CAPA processes, as well as experience with AI/ML, automation, and Robotic Process Automation (RPA) is a plus.
- Strong facilitation skills with excellent organizational and interpersonal abilities.
- Willingness to continuously improve and grow with new challenges
- Willingness to travel as required.
840
Kosice
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our
Project Services
- Lead and oversee computer system validation (CSV) efforts for life sciences clients, ensuring adherence to regulatory requirements such as 21 CFR Part 11 and 21 CFR Part 820, but not limited.
- Develop and implement comprehensive lifecycle documentation for GxP relevant computer systems, including the creation and execution of test protocols.
- Review technical documentation and support IT compliance strategies to maintain the security, reliability, and regulatory compliance of computer systems.
- Collaborate with cross-functional teams, including IT, Quality, and Regulatory, to design and execute validation plans for both new and existing computer systems and digital initiatives.
- Provide expert guidance and support on CSV and automation testing, ensuring best practices and regulatory compliance.
- Experienced in DevOps, Agile, Scrum, Waterfall, and ITIL methodologies, with a strong understanding of industry best practices.
1
- Bachelor’s or master’s degree in computer science, Engineering, Pharmaceuticals, or a related field.
- Minimum of 4 years of experience in computer system validation (CSV), hardware qualification, IT compliance, testing automation, or related disciplines.
- In-depth knowledge of relevant regulations and industry best practices, including FDA regulations, EudraLex and GAMP5.
- Proven ability to lead and manage multiple CSV projects and digital initiatives, including documentation development, testing efforts, and compliance assurance.
- Experience with testing automation tools, process-controlled systems, application lifecycle management tools and paper-based testing
- Strong communication skills with the ability to work effectively with cross-functional teams
- Expertise in cloud-based solutions, SAP, Clinical Trial Management Systems (CTMS), Veeva Vault, Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), electronic Lab Notebooks (eLN), change management, deviation and CAPA processes, as well as experience with AI/ML, automation, and Robotic Process Automation (RPA) is a plus.
- Strong facilitation skills with excellent organizational and interpersonal abilities.
- Willingness to continuously improve and grow with new challenges
- Willingness to travel as required.
840
Kosice