Your responsibilities:

Determine validation approach, identify deliverables needed or impacted by a project/enhancement / or change for GXP computerised systems
Review of software documentation according to CSV corporate SOP's, and regulatory guidance
Provide estimates and forecast validation activities for a project
Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go life
Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards
Participate actively in validation discussions, and provide consultancy for all validation-related questions
Review and collect expected CSV deliverables, records and other evidences according to plans
Prioritize activities in line with the project schedules, business needs and compliance requirements
Ensure code release to production and maintenance procedures are identified and adhered to
Confirm initial data loading and/or data migration from other systems, are performed according to approved procedures
Assess changes to determine potential impact to the validated state of the computerised system
Support system maintenance with validated state and permanent audit readiness
Observe governance processes, escalates area for improvement
Support system audit/inspection preparation and execution as CSV subject matter expert
Implement relevant framework and processes, propose and uses tools
Provide training and validation/quality knowledge/experience exchange support

We're looking for you, if you have:

3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
Mandatory Experience in Lean and/or Agile approaches
Experience in leading validation for projects and systems maintenance
Experience in authoring validation plans, reports and deliverable registries
Experience in authoring or reviewing validation related deliverables, records and other evidences
Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated)
Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11
Aware of common development technologies and governance processes impacting validation approaches
Ability to work collaboratively in cross-functional teams to achieve milestones and goals
Ability to communicate clearly and professionally both in writing and verbally
Ability to share knowledge and guide others
Ability to make sound decisions about quality and technical subjects
Follow-through and persistence : our team is globally spread and some key stakeholders, due to extremely busy schedules, will need chasing up for input/signatures
Higher education degree or relevant work experience in computer science, software engineering, information systems and/or pharma industry
Communication skills, English language mandatory (C1)
Assertiveness, conflict management skills, leadership skills
Hands-on experience with Retina or JIRA (Backlog Management)
Hands-on experience with ServiceNow (Incident, Change, Knowledge Management)
Professional Scrum or SAFe Certification is an advantage (will be mandatory to be obtained within 6 months after joining)

Senior Validation Specialist

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