It Validation Consultant (Pharma)

TL;DR

IT Validation Consultant (Pharma): Ensuring validation activities are planned and executed according to validation strategies, GxP requirements, and SOPs, maintaining the validated state of systems throughout their lifecycle with an accent on compliance and risk-based approaches. Focus on collaborating with stakeholders, managing system discrepancies, and driving continuous improvement in validation processes.

Company

hirify.global is an independent technology consulting firm providing guidance and solutions to businesses with more than 1000 clients across the globe.

What you will do

• Ensure validation activities are properly planned and executed according to validation strategies, GxP requirements, and applicable SOPs.
• Maintain the validated state of the system throughout its entire lifecycle.
• Collaborate with Quality Assurance (QA) on compliance-related topics.
• Oversee testing activities, including review and approval of executed test cases.
• Manage and resolve system discrepancies in collaboration with global system roles.
• Drive continuous improvement by optimizing and simplifying validation processes using risk-based approaches.

Requirements

• Degree in Business Administration, Computer Science, or comparable professional experience.
• Around 4 years of 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.
• Experience in developing and delivering training on KBs and SOPs aligned with the Validation Plan and AAP.
• Excellent written and spoken English.

Nice to have

• Familiarity with ITIL v4.

Culture & Benefits

• Grow rapidly with a tailored career path and salary evaluation.
• 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.
• Benefit from our WeCare program, supporting employees in critical situations.
• Unleash your full potential, both professionally and personally.

Hiring process

• Brief Call: Virtual/phone conversation to understand your motivations and ensure the right job fit.
• Interviews: Meet team members to discuss your experience, skills, and career opportunities at Amaris.
• Case study: Depending on the position, you may be asked to take a test (role play, technical assessment, problem-solving scenario, etc.).