QA Engineer
IRT/RTSM Specialist
Mexico City
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Astellas’ Global Capability Centres – Overview
Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Working Environment and Location
This position is based in
Mexico City (Santa Fe area)
and will require on-site work in a hybrid set up.
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose and Scope
As a IRT Specialist of a series of applications in various areas of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Responsibilities will include a thorough understanding of SLC processes to ensure oversight of the implementation of digital health and eSource systems like IRT/RTSM, eConsent and wearable (primary focus is IRT). In addition, this individual will be responsible for computer systems validation activities and will have the skill set and experience to be able to make an immediate impact. The specialist will contribute to the implementation of requirements and not be limited to vendor collaboration. The development, execution, and continued validation related to the CSV guidelines and procedures, which will underpin the validation of the facilities various software systems and their ongoing maintenance and upgrade.
You will be at the forefront of ensuring software is implemented appropriately and ensuring that the highest level of quality goes into the critical tasks of Requirements, Development, Validation and User Acceptance Testing.
Role and Responsibilities
- To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
- To identify and document computer systems which impact upon GxP and aid in the performance of the validation of identified systems.
- To quickly gain a detailed understanding of current CPI and vendor validation strategies and documentation packages for the validation and UAT of ongoing projects.
- Hold expertise in validation procedures and performance in line with GAMP5 guidance and how this is applied to highly complex automated systems.
- Oversee the installation and software testing processes relevant to future projects provided by vendors.
- Ability to generate (create and write) user acceptance scripts
- Manage the validation full lifecycle of the software systems ensuring that they operate in compliance with GxP/ GAMP5 requirements.
- Maintain appropriate validation documentation and files according to cGMP and CPI validation policies and procedures.
- Continuous Learning: Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in a specific area of expertise.
- Innovation: Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities.
- Problem-Solving: Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions.
- Quality Assurance: Ensure the highest quality and consistency in the work delivered.
- In-depth experience of operating at an expert level in CSV.
- Will possess significant CSV expertise and experience of operating in a GMP environment, developing, and implementing validation programmes
Essential Qualifications
- IRT/RTSM System experience – Individual must have directly support this system at vendor and/or sponsor level
- Educated to Degree level, preferably in an IT / Infrastructure Management subject or a Life Science subject (or with demonstrable, significant GMP / industrial experience, particularly in CSV).
- Demonstrated experience in developing and configuring in the RIM/Quality Docs space using Veeva Vault platform.
- Business Process Understanding: Knowledge of Submissions Management/ Quality Document management business processes and how Vault RIM/QD supports these processes.
- Agile and adaptable to changing environments and project scopes.
- Able to support technical upgrade on six times a year basis by conducting technical impact assessment, addressing any technical issues, support the environment management, support testing, and document changes per the SLC process.
- Manage user account, create roles, and support quarterly user access review request.
- Support system deliverables and provide technical feedback during internal and external Veeva Clinical system audit.
- Work closely with the internal privacy and security team to assess Personal Information requests and act according per the privacy laws.
- Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during the technical upgrade.
Preferred Qualifications
- 1-3 years demonstrated experience with supporting application validation and UAT. Must also demonstrate understanding of how to execute validation related documents such as test scripts.
- Validation Champion: Adherence to Validation and UAT principles. Ability to lead by example when it comes to validation documents as well as validation proficiency, execution and oversight. Must be able to not only create documents but also oversee the process per established process.
- Technical Proficiency: Strong technical skills to understand how system details relate to validation details. Be able to not only administer and execute validation activities but also support end users and triage and respond to system issues.
- System Skills: Office 365, Sharepoint, Teams, SQL, ALM validation software or equivalent.
- Fluent in written and spoken business English and Spanish.
Benefits
Careers | Astellas
Why Astellas
- We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks.
- People who act with unwavering integrity and are deeply committed to making a tangible impact.
Learn more at Astellas.com
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