Computer Systems Validation Specialist

4 weeks ago


Swadlincote, Derbyshire, United Kingdom Healthnet Homecare Full time
Computer Systems Validation Engineer

HealthNet Homecare is a leading provider of homecare services, delivering specialized care to patients in their own homes. Our team is dedicated to making a positive impact on patients' lives, and we're seeking a highly skilled Computer Systems Validation Engineer to join our IT department.

The ideal candidate will have a strong background in computer system validation, with expertise in regulatory compliance, quality assurance, and software lifecycle management. This role requires a detail-oriented individual with excellent analytical and problem-solving skills, as well as exceptional communication and interpersonal skills.

Main Responsibilities
  • Validation Planning and Execution: Develop comprehensive validation strategies and plans for computer systems, including defining the scope, approach, resources, and schedules.
  • Regulatory Compliance: Ensure all computer system validations are conducted in accordance with relevant regulatory requirements and industry best practices.
  • Documentation Management: Lead the creation and review of all validation documentation, including validation plans, test protocols, and final reports.
  • Coordination: Coordinate with cross-functional teams including IT, Quality Assurance, and Operations to ensure alignment on project goals.
  • Risk Management: Conduct risk assessments and implement risk management strategies throughout the validation lifecycle.
  • Process Improvement: Continuously improve validation processes and procedures by implementing innovative approaches and adopting new technologies.
  • Stakeholder Engagement: Serve as the main point of contact for all matters related to computer system validation. Communicate effectively with internal stakeholders and external auditors or inspectors.
  • Training: Develop and deliver training materials related to CSV practices to ensure team and company-wide awareness and understanding.
Requirements
  • Education: Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field.
  • Experience: At least 2 years of experience in computer system validation within a regulated environment, preferably in pharmaceuticals or biotechnology.
  • Skills: Strong knowledge of GAMP 5 guidelines, 21 CFR Part 11, Annex 11, and other relevant regulatory standards.
  • Personal Qualities: Proven leadership skills, excellent project management skills, and exceptional communication and interpersonal skills.
What We Offer
  • Competitive Salary: A competitive salary structure and benefits package, including pension scheme, ongoing training and development, and professional registration fees paid.
  • Professional Growth: Opportunities for career advancement and professional growth, with a focus on developing skills and expertise in computer system validation.
  • Collaborative Environment: A collaborative and supportive work environment, with a team of experienced professionals who are passionate about delivering high-quality care to patients.


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