JOB PROFILE: Computer SystemValidationSpecialist
INCUMBENT’S NAMEJOB 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
- 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
- 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
Page 1 of 2