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Our Edinburgh based client within the biotech space are looking to bring in a Computer Systems Validation (CSV) Specialist on a 6-month fixed-term contract.
This is a great opportunity to join a highly regulated environment where you’ll support validation activities, system compliance, and documentation across GMP-compliant digital systems. Ideal for someone with prior CSV experience in life sciences
You will be a key member of our Quality Assurance team and will act as the subject matter expert for CSV projects. In projects, as the CSV lead, you will monitor key milestones ensuring the availability of documented evidence to evidence these. You will also provide CSV support to all areas of the business on a day-to-day basis, including guidance on best practices for the qualification and validation of systems to GMP
Responsibilities:
* Supporting the continual development of Data Integrity within the QMS.
* Actively participating in Data Integrity assessments across the site, providing CSV input.
* Ensuring IT systems, products and services are delivered, installed, validated and maintained throughout their lifecycle to ensure compliance with regulatory requirements and best practice.
* Providing CSV support to all areas of the business including operation and retirement of suitable qualified/validated computer systems in accordance with current GXPs and SOPs.
* Providing advice and guidance on best practices for the qualification and validation of IT services and systems on a day-to-day basis in order to meet the goals and objectives of the business.
* Creation and support of implementation of governance of company policies relating to computer systems.
* Performing quality audits for prospective automated equipment & applications vendors to determine compliance with CSV processed.
* Conducting periodic evaluation of computer systems to confirm that they remain in a valid state and are compliant with GMP.
* Participation in testing phases of projects as required.
* Review and delivery of training for CSV and compliance training at various levels across the business.
* Maintenance of an up-to-date knowledge of international regulatory requirements for CSV.
Qualifications Required:
You will hold a degree in a Life Science or Computer Science subject or equivalent relevant experience.
Knowledge/Skills/Experience Required:
* Experience in GMP regulations in relation to Computer Systems Validation.
* Experience in project-based work, including activities such as regulatory audits, GAP analyses and risk assessments.
* Laboratory Systems experience
* Prior knowledge of electronic validation software tools (ValGenesis, Kneat)
* Exceptional organisational and planning skills with the ability to plan ahead whilst delivering results to deadline.
* Excellent communication and interpersonal skills and a proven track record in negotiation whilst maintaining effective relationships.
* Excellent oral and written communication skills; able to explain technical or complex concepts in a clear format to both technical and non-technical audiences
* Able to effectively manage and influence stakeholders’ and customer expectations
* Excellent administration and record keeping skills.
* Ability to learn and share knowledge with the management team and the wider team where appropriate.
* Excellent attention to detail with a desire to continually develop and improve our processes
Apply above or reach out to me at [emailprotected] for a confidential discussion about the opportunity
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