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Senior 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 Senior Validation Specialist

  • Position: Senior Validation Specialist
  • Technologies: Validation, CSV, SDLC
  • Location: Remote
  • Country: Poland
  • Area: Project
  • Form of employment: B2B
  • Experience Level: Senior

The main tasks for the Senior Validation Specialist will be:
  • Defining authentication approach, recognizing deliverables needed or affected by a project / enhancement / or change for GXP computerised systems
  • Being responsible for the evaluation of software documentation according to CSV corporate SOP’s, and regulatory guidance
  • Providing estimations and forecast validation activities for a project
  • Creating validation plans/reports, reviewing test plans/reports (and other deliverables) to asses and notify that system is ready to go life
  • Establishing testing strategy, requirements and acceptance criteria
  • Cooperating with business quality/informatics quality to guarantee compliance with corporate quality policies and standards
  • Coordinating and advising on all validation activities on a global level/organizational level for system/project
  • Participating actively in validation discussions, provide consultancy for all validation related questions
  • Joining system implementation and maintenance planning
  • Leading system and functional risk assessments
  • Providing verification of testing plans, activities, deliverables and records, providing consultancy on test related deviations and corrective actions
  • Reviewing and collecting expected CSV deliverables, records and other evidences according to plans
  • Prioritizing activities in line with the project schedules, business needs and compliance requirement
  • Ensuring code release to production and maintenance procedures are identified and adhered
  • Confirming initial data loading and/or data migration from other systems, are performed according to approved procedures
  • Assessing changes to determine potential impact to the validated state of the computerised system
  • Supporting system maintenance with validated state and permanent audit readiness
  • Helping system audit/inspection

The Candidate should have:
  • Working background in IT & Software Validation (CSV, GAMP), ideally in pharmaceutical field (3+ years)
  • Experience in
    • Conducting validation for projects and system maintenance
    • Developing validation plans, reports and delivery records
    • Creating or revisioning validation related documents, records and other evidences
    • Software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated)
    • Lean/Agile approaches
    • Maintenance and support applications within global control 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
    • Share knowledge and guide others
    • Make sound decisions about quality and technical subjects
  • Higher education degree or relevant work experience in computer science, software engineering, information systems and/or pharma industry
  • Assertiveness, conflict management skills, leadership skills
  • 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)

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

If you meet the requirements described above, please send your application in English (.doc) at marta.gorynia@seargin.com stating the name of the position in a subject and/or call +48 501 004 871.

 

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    ABOUT COMPANY
    Company size: 500+
    Main location:Poland
    Seargin Sp. z o. o.
    Remote, Poland
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