Skill and Competency Requirements
Five to Ten years of experience in a GXP environment or validation of IT applications, or an equivalent combination of education and experience.
Knowledge of GXP and EU regulations including 21 CFR Part 11, Risk-driven System Development Life Cycle (SDLC) methodologies, and Change Management Processes
Experience in the implementation and validation of stand-alone IT applications as well as complex enterprise systems such as Oracle LSH, RAVE, and Clinical Systems.
Technical proficiency, attention to detail, creativity, innovation, and independent thought.
Good communication, interpersonal, technical writing skills, proficient computer skills, experience with Document Management Systems (such as Documentum) and (preferably) software tools
Must be conscientious, dependable, adapt well to change, and work effectively with a global / culturally-diverse team.
As a member of a Business Service (BS) Validation Team, you will provide support in development of GxP Documentation Deliverables in BS System Development projects. Broadly, Business Services is responsible for the supporting processes for the commercial, administrative and scientific areas of Bayer. As integral part of the Group, Business Services significantly contributes to turn the Bayer Life Science strategy into execution. The portfolio ranges from developing and operating systems solutions to the design and operation of end-to-end business processes, augmented by management consulting.
POSITION DUTIES & RESPONSIBILITIES
Lead planning, creation, review, and execution of GxP documentation deliverables (plans, protocols, tests, reports, etc.).
Ensure GxP document deliverables are in compliance with Site and Corporate policies and procedures following a Risk-based Lifecycle Approach from URS development through system retirement.
Maintain System Validation, Data Integrity, CFR 21 Part 11 Compliance, in Change Management Process
Work closely with business stakeholders, technical support groups, and QA to thoroughly investigate validation discrepancies and drive best-practice for systems validation;
Self-Motivated / Self-Starter, will work independently with little direction on routine assignments and work on problems of diverse scope where a solution is not readily apparent
Strong commitment to continually improve the software development process through process improvements and the use of software tools
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|Years of Experience ||5+ to 10 years|
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