Take your career to the next level with Amaris Consulting as a IT Validation Manager (Pharma). Become part of an international team, thrive in a global group with €800M turnover and 1,000+ clients worldwide, and an agile environment by planning the kickoff and follow-up on projects. Join Amaris Consulting, where you can develop your potential and make a difference within the company.
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WHAT WOULD YOU NEED?
* Degree in Business Administration, Computer Science, or comparable professional experience
* Around 4 years of experience proven experience in validation within a GxP-regulated environment, preferably in an IT area
* Strong knowledge of GAMP5 (v2) principles and their practical application
* Ability to quickly learn and manage system lifecycle documentation (e.G. Validation Plan, URS, Functional Specifications, Risk Assessments, Test Reports, AAP, etc.)
* Experience in developing and delivering training on KBs and SOPs aligned with the Validation Plan and AAP
* Familiarity with ITIL v4 is considered an advantage
* Excellent written and spoken English
* Proven ability to work effectively in a virtual, international, and multicultural environment
* Strong organizational, analytical, and problem-solving skills, with a results-driven mindset
* Excellent communication, collaboration, and stakeholder management skills
WHAT WILL YOU DO?
* Ensure that all validation activities are properly planned and executed in accordance with validation strategies, GxP requirements, and applicable SOPs prior to system go-live
* Maintain the validated state of the system throughout its entire lifecycle
* Collaborate closely with Quality Assurance (QA) on compliance-related topics
* Coordinate with System Owners, Process Owners, Business Process Owners, System Leads, Developers, and other key stakeholders
* Ensure that all system-specific SOPs and System Lifecycle (SLC) documentation are in place before system operation
* Oversee testing activities, including review and approval of executed test cases
* Provide audit support and maintain up-to-date system documentation and presentations
* Manage and resolve system discrepancies in collaboration with global system roles
* Drive continuous improvement by optimizing and simplifying validation processes using risk-based approaches
WHY US?
Join our dynamic team of talented individuals and experience a world of growth and opportunities. Here's what we offer:
* Grow rapidly with a tailored career path and salary evaluation – 70% of our senior leaders started at entry level
* Enhance your skills through our Tech Academy catalog, Udemy E-learning Platform, Language Sessions, webinars, and workshops
* Take charge of your development with an annual personal training budget and company-paid certifications
* Enjoy flexible policies, remote work options, and fantastic social benefits like transit and restaurant tickets, kindergarten support, and private health insurance
* Benefit from our WeCare program, supporting employees in critical situations
* Unleash your full potential, both professionally and personally
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. xqysrnh For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.