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Business Solutions Associate
3 months ago
Who are we?
- A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence- 20 plus years of experience, ~500 people managing 39+ geographical locations throughout the Asia-Pacific region, USA, and Europe- Full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration, and post-marketing trial- We combine scientific leadership and global operational excellence, with strong experience in renal medicine, oncology, cardiovascular and chronic diseases across various phases to improve the health of millions worldwide.
Why work with us?
- We are a global team making a difference in the world – our clinical trials improve the health of millions worldwide- Competitive salary and benefits- Flexible and agile working arrangements - onsite, hybrid, or WFH (dependent on location)- Strong and diverse Learning & Development opportunities including exposure to all aspects of clinical trials with an unparalleled network of Scientific Leaders to learn from- A focus on employee wellbeing including global employee engagement surveys, steps challenges, reward and recognition programs, team building activities, and other fun events
About the role:
The purpose of this role is to ensure the compliance and effectiveness of GxP computer systems within the organization. The GxP System Validation Specialist will achieve this by:
- Managing the GxP system validation lifecycle: This involves overseeing all stages of validation, from planning to ongoing maintenance and integrations.- Developing testing/validation plans executing the tests confirming system meets GC requirement: This ensures a systematic approach to testing and verifying system functionality.- Maintaining validation documentation: Proper documentation is crucial to demonstrate compliance and audit readiness.- Mitigating system risks: The specialist proactively identifies potential issues and implements solutions to safeguard data integrity and system performance.- Staying current with GxP regulations: Adapting to evolving regulations ensures the validation process remains effective.
Key Accountabilities:
- Manage all aspects of the GxP system validation lifecycle, including planning, design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and revalidation.- Develop and execute comprehensive validation plans and test protocols to ensure thorough system testing.- Perform gap analysis to identify any deviations from GxP requirements.- Prepare and maintain all validation documentation, including test plans, test scripts, test reports, and validation summaries.- Conduct risk assessments and develop mitigation strategies to address potential system vulnerabilities.- Liaise with internal stakeholders (e.g., IT, Quality Assurance) and external vendors to ensure smooth execution of the validation process.- Stay up-to-date on the latest GxP regulations and industry best practices for system validation.- Participate in continuous improvement initiatives to optimize the validation process.
What are our expectations of candidates?
- Minimum of 4-5 years of hands-on experience in GxP system validation.- Prior experience with Electronic Data Capture (EDC) application validation is highly preferred.- Strong understanding of GxP regulations (e.g., GAMP 5 and GCP) and their application to computerized systems.- Excellent knowledge of validation methodologies (IQ, OQ, PQ, revalidation).- Proven ability to develop and execute comprehensive validation plans and hands on system testing using UAT test scripts.- Excellent documentation skills with a strong attention to detail.- Ability to manage and prioritize multiple tasks simultaneously.- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).Strong analytical skills
We are searching for individuals who are excited by the idea of regional and global projects and teams, don’t want to get lost in a large CRO and are ready to have their ideas heard
You will be willing to extend yourself and take on new challenges while living our values of Mutuality, Integrity, Can-do approach, Empowerment and Excellence.
How do I apply and what if I'm interested in a role in future or want to refer someone?
Apply via LinkedIn or send your CV, referral or confidential query to and our friendly HR team across the world will reach out as appropriate soon. Please provide your full contact details, the location you are applying for, whether you are interested in a current or future opportunity and we'll be in touch. We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.
How do I learn more about the roles and George Clinical?
Follow us on Linkedin to see our regular updates and how we celebrate our people and success across our business and projects You can also visit us at are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.
Thank you for your interest in working with George Clinical. As a global business, we are committed to handling Personal Information in accordance with applicable privacy and data protection laws in the many countries in which we do business. Please see our Privacy Policy for further information.
