Senior Validation Specialist

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)