Senior Validation Specialist

Our requirements

• 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)

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

What we offer

• Participation in interesting and demanding projects.
• Flexible working hours.
• A great, non-corporate atmosphere.
• Possibility to work remote or hybrid (2 days per week from the office).
• Opportunities for development and promotion.
• Attractive package of benefits.

Benefits

• sharing the costs of sports activities
• private medical care
• sharing the costs of foreign language classes
• sharing the costs of professional training & courses
• life insurance
• flexible working time
• fruits
• integration events
• no dress code
• extra social benefits

Transition Technologies MS S.A.