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Validation Specialist
Company name: Seargin Sp. z o.o
Company size: 500+ people
Junior
Professional
Senior
Remote, Poland
Job Specification
  • Remote
  • Remote

Website Seargin_ Seargin Sp. z o.o

THE ELITE OF TOP IT EXPERTS

Seargin is looking for a Validation Specialist

  • Position: Validation Specialist
  • Location: remote
  • Technologies: CSV, GAMP, Agile
  • Type of contract: b2b (freelance)
  • Area: project

Main tasks for the Validation Specialist will be:

  • Determines validation approach, analyzes deliverables needed or impacted by a project / enhancement / or modification for GXP computerised software
  • Take responsibility for the overview of software documents according to CSV corporate SOP’s, and regulatory guidance
  • Provide evaluations and forecast validation activities within a project
  • Create validation plans/reports, reviews test reports to asses and inform that system is ready to function
  • Find best testing strategy, requirements and acceptance standards
  • Liaison with business quality/informatics quality to guarantee compliance with company quality rules and standards
  • Control, manage and advise on all validation activities on a worldwide level/organizational level for system/project
  • Actively take part in validation discussions, provide consultancy and answer for all questions associated with validation
  • Take part in system implementation and maintenance mapping
  • Lead and author system and functional risk assessments
  • Identification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and appropriate actions
  • Overview and gather expected CSV deliverables, records and other evidences according to plans
  • Distinguish category of activities in line with the project schedules, business requirements and compliance
  • Guarantee that code released to production and maintenance rules are checked and adhered
  • Accept initial data loading and/or data migration from other systems, are performed according to approved procedures
  • Apply changes to determine potential impact to the validated state of the modernized software
  • Support system maintenance with validated state and permanent audit readiness
  • Lead and author system periodic review according to procedure
  • Observe governance processes, escalates area for improvement
  • Supports system audit/inspection preparation and execution as CSV subject matter expert
  • Assures strategic and essential oversight over validation support within department and provides consulting support for the team and global organization as required.
  • Applies relevant framework and processes, suggest and uses new technologies
  • Organize training and validation/quality knowledge/experience exchange support
  • Creates recommendations for process optimization in area of influence.
  • Provide input and guidance for a automatized system retirement planning

The Candidate should have:
  • Minimum 3 years of experience in IT & Software Validation (CSV, GAMP)
  • Experience
    • in supervising validation for projects and systems maintenance
    • in authoring validation plans, reports and deliverable registries
    • in authoring or overviewing validation associated deliverables, records and other evidences
    • 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
  • Keep up with common development technologies and governance processes impacting validation approaches
  • Ability
    • to collaborate in function-mixed teams to achieve milestones and objectives
    • to communicate clearly and professionally both in writing and verbally
    • to share knowledge and guide others
    • to make sound decisions about quality and technical subjects
  • Higher education degree or relevant work experience in computer science, software engineering, information systems or pharmaceutical industry
  • Team-oriented, detail-oriented, efficient and solution-oriented attitude
  • Superb analytical and problem solving skills
  • Excellent communication and interpersonal skills
  • Flexibility and ability to work independently and in a team
  • Great English skills (written and spoken)

It would be a plus if the Candidate had: 
  • Pharma environment experience

The Candidate can expect:
  • B2B Contract
  • Challenging job in an international and multilingual environment
  • Professional development
  • Attractive and competitive compensation

If you meet requirements described above, please send your application in English (.doc) at bernard.hudzik@seargin.com, stating the name of the position in a subject and/or call +(48) 515 275 188.

 

 

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    Your personal data is processed by Seargin Sp. z o.o. Data protection inspector can be reached via email address RODO@Seargin.com.
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    ABOUT COMPANY
    Company size: 500+
    Main location:Poland
    Seargin Sp. z o.o
    Remote, Poland
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