Digital and Business Compliance Analyst, PlatformX
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.
At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their caregivers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
As an Agile Digital and Validation analyst, you plays a crucial role in the software life cycle (SLC), focusing on ensuring the quality, reliability, and performance of software products its deliverables within agile development environments.
You will be involve in integrating SLC and computer systems validation (CSV) processes into the agile workflow, working collaboratively with cross-functional teams to identify and address potential issues early in the development cycle.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Activities:
- Agile Collaboration: Actively participate in agile ceremonies such as sprint planning, daily stand-ups, sprint reviews, and retrospectives to integrate SLC and Validation perspectives from the outset of project planning through to execution.
- Continuous Testing: Implement continuous testing strategies that align with agile methodologies, ensuring that testing is an integral part of the development process from the beginning to the end of each sprint.
- System Life Cycle (SLC) - Review and approval of SLC deliverables as part of the change management process. Create and author validation deliverables i.e., Validation Plan and Report.
- Computer Systems Validation: Ensure that all changes meet the requirements of SLC/Computer Systems Validation process
- Quality Metrics and Reporting: Track and report on key compliance metrics, such as CAPA. Use this data to make informed decisions about risk and quality. Support performing application periodic reviews.
- Stakeholder Communication: Communicate effectively with project stakeholders, including product owners, developers, business users and the Quality Assurance organization, to ensure a clear understanding of SLC deliverables, validation best practices.
- Process Improvement: Continuously evaluate and improve SLC and validation processes to enhance team agility and software quality. Support all initiatives related to compliance and validation.
- Audit: Support all audits and inspections around SLC/Computer Systems Validation.
Essential Knowledge & Experience:
- Relevant experience in agile software development and quality assurance, demonstrating a track record of successful implementation of SLC and validation strategies in agile environments.
- Strong background in Computer Systems Validation and System Development Life Cycle.
- Strong analytical and problem-solving skills.
- Ability to work effectively in a team environment.
- Excellent communication skills, both written and verbal.
- Five years of relevant experience working in computer systems validation in the pharma/medical device sector
- SOX/IT Audit experience a plus.
Preferred experience:
- Background in Computer Systems Validation/Part 11 compliance.
- Ability to create and approve SLC deliverables with quality.
Education/Qualifications:
- Bachelor’s degree in relevant field, e.g., Computer Science, Data Science, Business Administration. (or equivalent experience).
Additional information:
- This is a permanent role based in Poland. Role requires a blend of home and minimum once or twice a week in our Warszawa Poland office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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