Let’s do this. Let’s change the world. In this vital role you will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes in tools like Veeva Study Startup. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements.
The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated.
Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications.
Defining the scope, objectives, and approach of the validation process, creating detailed validation plans, and aligning them with project timelines and resources
Perform Validation testing, including Installation Qualification (IQ), Operational Qualification (OQ) for new and existing SSU Systems
Ensure compliance with industry standards, regulations and internal policies during all validation activities. (GxP, FDA 21 CFR Part 11)
Identify, document, and track defects during the testing process.
Collaborate with development teams to define validation requirements, resolve defects and validate fixes.
Maintain comprehensive audit trails and validation documentation to support regulatory inspections.
Configure and optimize workflows within the Veeva Vault Management (VVM) to streamline test management and approval processes.
Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements.
Act as a liaison between technical teams and stakeholders to ensure system requirements are met.
Provide training to end-users on Veeva VM Testing Vault functionalities and best practices.
Assist in the development and continuous improvement of validation processes and procedures
Stay up to date with industry trends, best practices and evolving regulatory needs
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master’s degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR
Bachelor’s degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR
Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Preferred Qualifications:
Solid understanding of GxP regulations, specifically 21 CFR Part 11.
Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc.
Experience in defining and executing validation strategies aligned with regulatory requirements
Familiarity with risk-based approaches to validation
Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ))
Excellent documentation and report writing skills
Proficiency in automation tools, data systems, and validation software.
Experience of DevOps, Continuous Integration and Continuous Delivery methodology
Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies
Professional Certifications (please mention if the certification is preferred or mandatory for the role):
SAFe for Teams certification (preferred)
Veeva VM certification (preferred)
Able to work under minimal supervision
Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work
Excellent analytical and gap/fit assessment skills
Strong verbal and written communication skills
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation
Ability to manage multiple priorities successfully
Team-oriented, with a focus on achieving team goals
Strong presentation and public speaking skills
This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours.
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
for a career that defies imagination
Objects in your future are closer than they appear. Join us.