Roles & Responsibilities
Advising clients on how to meet compliance requirements using a risk-based approach.
Develop validation documentation and standard operating procedures for various GxP applications.
Develop test protocols that thoroughly test business requirements.
Provide test execution oversight and assist with deviation recommendations as required, work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements.
Work with client business functions and subject matter experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required
Development of test / validation scripts based on software design and configurations.
Develop IQ/OQ scripts as required.
Basic Qualifications
Master’s degree with 8 - 12 years of experience in validation/regulatory or related field OR
Bachelor’s degree with 10 - 14 years of experience in validation/regulatory or related field OR
Functional Skills
Must-Have Skills
Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP
Experience with regulatory agencies – FDA, EMEA, CFDA, and other regulatory agencies
Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice.
Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
Expertise with ALM testing and ALM software
Expertise in use – Veeva (all modules – CDocs, QMS, RIM, DocuSign, etc)
Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance.
Preferred Skills
Ability to work independently, excellent problem solving and professional written communications skills.
Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets, Salesforce, Tableau a plus
FDA Audit experience a plus & working with regulatory agencies
Experience with instrument qualifications (IQ/OQ), validation plans, regulated workflows.
Soft Skills
Excellent leadership and team management skills.
Strong transformation and change management experience.
Ability to work effectively with global, virtual teams.
Excellent analytical and troubleshooting skills.
Ability to manage multiple priorities successfully.
Strong presentation and public speaking skills.
Strong verbal and written communication skills.
High degree of initiative and self-motivation.
What you can expect of us
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.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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