Radius Health, Inc.

IT Computer Systems Validation (CSV) Specialist

US-MA-Waltham
1 week ago(1/12/2018 11:52 AM)
Job ID
2018-1676
# of Openings
1
Category
Information Technology

Overview

The IT Computer Systems Validation (CSV) Specialist is responsible for supporting system validation activities across all Radius GxP applications.

    • Execute Computerized System Validation (CSV) activities according to GAMP 5 guidance
    • Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures
    • Translate technical information and requirements into qualification/validation test design
    • Work closely with Radius Quality Assurance
    • Cross Functional Role, Hands-on role

Responsibilities

  • Guides system stakeholders through the SDLC process and drafts and/or reviews and edits project related validation deliverables (Risk Assessments and Validation Determinations, Validation Master Plans, User/Functional/Technical Requirements, IQ/OQ and PQ/UAT Test Protocols and Scripts, Traceability Matrices, Validation Summary Reports).
  • Drafts policies, standard operating procedures, and work instructions supporting the computerized/IT infrastructure systems.
  • Participate in site IT Audits to ensure compliance to regulatory guidance and to policies and procedures.
  • Participate in Supplier Audits and IT Services Quality Agreements to ensure compliant supplier management.
  • Assists, as necessary, with project management activities, including but not limited to the generation of project schedules, meeting minutes, and technical documents.
  • Serves as test coordinator/reviewer and where necessary, executes Test Scripts according to good testing and documentation practices.
  • Demonstrated experience and excellent knowledge of applicable CSV and IT regulations including the US FDA CFR’s, EU, ICH, as well as the GAMP guidance.
  • Working knowledge of Project Management and Software Development Life Cycles.
  • Familiarity with computer infrastructure, servers, workstations, operating systems and data base management systems.
  • Supports the compliance of Radius IT systems with applicable regulations (21 CFR 58, 210, 211, 820, and Part 11) and assists with SOX testing/compliance.
  • Supports the development and maintenance of Validated GXP IT System training materials and assists in conducting end-user training.
  • Drafts and executes CSV deliverables for computerized and IT infrastructure systems
  • Coordination of all aspects of computer systems validation activities including development of validation strategies, document development and document reviews, as well as planning and conducting applicable testing, conducting risk analysis, writing protocols and reports
  • Participate as needed in risk assessments
  • Support adherence to all relevant regulatory requirements, company standard operating procedures and client requirements as appropriate.
  • Interface with the Radius IT team, QA Validation and relevant business functions regarding system change requests and associated documentation and controls in accordance with requirements, design and system changes

Qualifications

  • Bachelor’s degree with Pharmaceutical or Scientific background preferred
  • At least 3-5 years of pharmaceutical of FDA related validation experience
  • Good knowledge of GMPs, 21CFR Part 11, USP 1058 – and other relevant industry regulations and guidance
  • Strong interpersonal skills and demonstrated ability work independently
  • Organized and task oriented
  •  Excellent written and oral communication skills – especially on technical topics
  • Self-directed and motivated individual who can operate in a rapidly changing business environment
  • Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
  • Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project
  • Ability to Build consensus among team of stakeholders
  • Excellent critical thinking/analytical and problem-solving skills

 

Radius Health is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius’ lead product, TYMLOS(abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. 

Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

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