Digital and Business Compliance Analyst

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .

This position is based in Bengaluru and will require some on-site work.

Purpose And Scope
An Agile Digital and Validation analyst 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. This role involves 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.

Essential Job Responsibilities

• 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.

Qualifications Required

• Bachelor's degree in relevant field, e.g., Computer Science, Data Science, Business Administration.
• 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

• Background in Computer Systems Validation/Part 11 compliance
• Ability to create and approve SLC deliverables with quality.

Working Environment

• This hybrid position will be based in Bengaluru with the expectation of in office presence 1-2/times a week.
• 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.

Category Platformx

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans