Senior Validation Specialist
New
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Transition Technologies MS S.A.Pharmaceutical software
Locations: Warszawa, Chmielna 69, Warszawa, Country code: PLFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English language mandatory (C1)
- Experience
- 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
- Required Skills
- AgileJiraServiceNow
Requirements
- Have 3+ years of IT and software validation experience with CSV and GAMP; pharma experience is preferred.
- Have experience with Lean and/or Agile approaches.
- Have experience leading validation for projects and system maintenance.
- Have experience authoring validation plans, reports, and deliverable registries.
- Have experience authoring or reviewing validation deliverables, records, and evidence.
- Understand SDLC processes, models, and standards in the pharmaceutical or another regulated industry.
- Have experience maintaining and supporting applications subject to global inspection agencies, CFR 21 FDA Part 11, and Annex 11.
- Have a higher education degree or relevant work experience in computer science, software engineering, information systems, and/or the pharma industry.
- Have English language proficiency at C1 level.
- Have hands-on experience with Retina or JIRA for backlog management.
- Have hands-on experience with ServiceNow for incident, change, and knowledge management.
- Be able to collaborate across functions, communicate clearly in writing and verbally, share knowledge, and guide others.
Responsibilities
- Determine validation approaches and identify project or change deliverables for GxP computerized systems.
- Review software documentation against corporate CSV SOPs and regulatory guidance.
- Estimate and forecast validation activities for projects.
- Author validation plans and reports, and review test plans, reports, and other deliverables for system readiness.
- Coordinate with business quality and informatics quality to ensure compliance with corporate quality policies and standards.
- Collect and review CSV deliverables, records, and evidence against approved plans.
- Assess changes for their potential impact on the validated state of computerized systems.
- Support system maintenance, audit readiness, and audit or inspection preparation and execution as a CSV subject matter expert.
- Confirm that production releases, maintenance procedures, and initial data loading or migration follow approved procedures.
- Provide validation consultancy, training, and knowledge sharing, and identify governance improvements.
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