Senior Validation Analyst / Validation Lead

Quick Facts

• Role: Validation Lead (Senior Validation Analyst)

• Domain: Pharmaceutical / GxP computerized systems

Description

Experienced Validation Lead to manage validation approach, deliverables, and system readiness for GxP computerized systems in the pharmaceutical industry. You will author and review validation plans/reports, define testing strategy and acceptance criteria, assess change impacts to validated state, and support maintenance for permanent audit readiness. You will also act as a CSV subject-matter expert for audit/inspection preparation and execution and provide oversight and consultancy for validation teams globally.

Responsibilities

• Determine validation approach and identify deliverables impacted by projects, enhancements, or changes

• Author validation plans/reports; review test plans/reports (and other deliverables) to ensure the system is ready to go live

• Determine testing strategy, requirements, and acceptance criteria

• Assess changes to determine potential impact to the validated state of the computerized system

• Support system maintenance to maintain validated state and permanent audit readiness

• Support audit/inspection preparation and execution as CSV subject-matter expert

• Provide strategic/essential oversight over validation support within the department and support/consultancy for teams globally if needed

Requirements

• 5–6+ years experience in IT & Software Validation (CSV, GAMP), preferably in a pharma environment

• Experience leading validation for projects and systems maintenance

• Experience with software development lifecycle processes (SDLC) and pharmaceutical/regulatory models and standards

• Experience maintaining/supporting applications under global inspection agencies, including CFR 21 FDA Part 11 and Annex 11

• Ability to share knowledge and guide others

• Fluent English in speech and writing

Benefits

• Comprehensive benefits: Udemy for Business, private medical care, Multisport card, veterinary package, language lessons, and shopping vouchers

• Flexibility: adaptable working hours and remote/hybrid work options

• Career growth and learning opportunities, including perks related to official partnerships with Microsoft, AWS, Snowflake, Salesforce, and more

• Global collaboration with an international team

• Innovative environment focused on growth and innovation

• Engaging community with team-building events, hackathons, and CSR initiatives

• Annual team-building company event in Mazury and a welcome pack