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Senior Validation Analyst

Eingestellt von Brainbridge

Gesuchte Skills: Support, Engineering

Projektbeschreibung

The Computer Systems Validation (CSV) Specialist will be responsible for adhering to the company's CSV and System Development Life Cycle (SDLC) requirements, developing systems validation documentation, requirements gathering and analysis, generating and executing test protocols and scripts and summarizing validation activities in reports. Working closely with developers, business analysts, project managers and business stakeholders, the CSV Specialist will play a key role throughout the system development life cycle (SDLC), from validation of a new system implementation through qualification of changes to existing systems, to assure that all critical systems remain in a validated state. Their focus will be on computerized systems in support of the "Product Lifecycle Registration" (PLcR) project, but may also be utilized as an expert for other projects under "Regulatory Information Management" (RIM) initiative in Global Regulatory Affairs (GRA).

Responsibilities:
•Assist in the management of computer systems validation for IT system(s) under PLcR and RIM
•Work closely with internal company Quality Compliance Coach in defining and executing validation strategy
•Generation of validation documentation for projects and change controls, which include validation/qualification plans, user requirements, functional and non-functional specifications, test plans, IQ, OQ and PQ protocols, test cases/scripts, traceability matrices and validation reports
•Development and execution of system testing, i.e. functional, compliance, user-acceptance, performance/stress, and adhoc testing
•Conduct risk assessments and periodic audits of systems and software development activities
•Ensures all systems and software are in compliance with relevant guidelines, i.e. JNJ SDLS and CSV, GxP, 21 CFR Part 11, GAMP, SOX
•Assist in the management of controlled documents
•Responsible for creating training materials related to validation projects, client-specific software applications and SOPs/Work Instructions
•Development of SOPs/Work Instructions in support of quality systems and software development

Technical skills:
•Experience in Software Development Life Cycle (SDLC) for computer systems is a must
•Working knowledge of GxP and 21 CFR Part 11 as they relate to computer systems validation
•Experience with Documentum and Hewlett Packard Quality Center/Application Lifecycle Management (QC/ALM) preferred
•Experience with testing and supporting Research & Development applications as well as business systems is desirable
•Business Analysis experience, particularly requirements gathering and analysis is a must
•Experience in Pharmaceutical Regulatory Affairs is a must
•Experience with Regulatory Planning & Tracking software tools is desirable
•Experience in data migration is preferred
•Excellent written and verbal communication skills, with hands-on experience working in a systems development environment, and as a productive and supportive member of a multidisciplinary team
•Experience with Client Server and Web applications

Personal skills:
Qualifications:
•BS or MS in computer science, life sciences, engineering or equivalent work experience
•Minimum five years validation experience in life sciences
•Past experience working as a CSV Specialist at one of our companies and familiarity with the company's SDLS and CSV requirements is highly preferred

•Some flexibility in working hours is required
•Must be able to work on multiple simultaneous tasks with limited supervision
•Quick learner
•motivated self-starter
•Excellent customer service, interpersonal, communication and team collaboration skills
•Able to follow change management for internal guidelines.
•English and Dutch spoken and written

Projektdetails

  • Einsatzort:

    Antwerpen, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Brainbridge