JOB PROFILE: Computer SystemValidationSpecialist

INCUMBENT’S NAME
JOB TITLE / Computer System ValidationSpecialist
BUSINESS UNIT / Quality Assurance
LOCATION / Worthing
REPORTS TO / Validation Manager
OBJECTIVES
PURPOSE OF JOB /
  • To help with the implementation of Computerised System across Rayner
  • To drive participate with improvements within CSV tasks and other areas as required
  • To work in partnership with departments across Rayner, in particular IT

KEY ACTIVITIES
RESPONSIBILITIES /
  • With a little assistance, determining validation requirements for computerised systems in accordance with a risk based approach
  • Build, maintain & disseminate current knowledge of regulatory requirements and industry best practice pertaining to validation
  • Assist in the development validation knowledge and skills throughout Rayner to ensure all personnel can fulfil their defined roles & responsibilities effectively
  • Assist withvalidation planning with cross functional teams to ensure that an appropriate risk-based approach is taken and then executed in accordance with Rayner procedures to meet project deadlines. This include support of the Change Control System.
  • Develop appropriate rationale for testing and where appropriate using statistical rationale
  • Manage all validation activities, which include the development, writing, execution, review and approval of the suite of documents including but not limited to: validation plans, validation protocols and report
  • Evaluate with some assistance, investigate and document non-conformances incidents and/or protocol deviations
  • Complete assigned non-conformance and CAPA investigations and prepare investigation reports
  • Participate in the development of the new processes, process transfers and continuous improvement and issue resolution
  • Assist in the identification compliance risk associated with Rayner Facilities & Systems and actions to mitigate risks to required levels
  • Support regulatory inspections and audits in order to present Rayner’s compliance status
  • Development of Standard Operating Procedures and Quality Plans
  • Provide technical input into regulatory submissions / regulatory enquiries
  • Provide guidance to project teams
  • Establishing a professional relationship with Suppliers, where appropriate
  • To undertake activities as identified by your line manager to support the business needs
Act in line with our company values:
  • Ambition – We have the drive to continuously improve
  • Integrity – We are accountable for what we doacting ethically and in the best interests of our customers, patients and stakeholders
  • Openess – We positively consider new ideas and challenges
  • Respect – We support each other and our customers to succeed

KEY PERFORMANCE INDICATORS / Based on annual performance objectives
Examples:
  • Producing Rayner documentation to the required quality and agreed timelines; e.g. Validation plans, validation protocols, testing rationales, reports etc.
  • Reviewing and approving supplier’s documentation to the required quality and agreed timelines
  • Execution of protocols to the required quality and agreed timelines.
  • Raising the awareness of CSV across all levels of the company.
  • Successful completion of audits and inspections to maintain certification

KEY RELATIONSHIPS / Internal:
  • IT
  • Quality
  • Regulatory Affairs
  • Operations
  • Customer Services
  • Finance
External:
  • Suppliers

CANDIDATE PROFILE:

QUALIFICATIONS/ TRAINING /
  • Degree in Computer Science, Science, Engineering or a related subject

EXPERIENCE
(E.g. health care industry, multinational company, what level/types of roles etc.) /
  • A minimum of two years in a CSV role or equivalent
  • Knowledge of ERP systems and other business system is advantageous
  • Knowledge of GAMP5 is advantageous
  • Knowledge of 21 CFR Part 11 & Orange Guide Annex 11 is advantageous
  • Experience of working in a Medical Device, Pharmaceutical or similar regulated industry

COMPETENCIES
(knowledge, skills and attributes – including language requirements, ability to travel, etc) /
  • IT Infrastructure awareness
  • Awarenessof how ERP systems and IT systems are used by a business
  • Awareness of Spreadsheet Validation
  • GAMP5 understanding/Risk Based Validation/Suitable CSV methodology
  • Excellent interpersonal skills
  • Excellent communication skills both written and verbal
  • Self-Starter / Team Player / Minimal Supervision
  • High standard of technical report writing
  • The ability to read, analyse and interpret scientific/analytical and technical reports and respond to enquiries from regulatory agencies
  • Must be able to plan, organise and implement multiple concurrent tasks
  • Ability to travel, as required

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