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Computer System Validation Specalist
hace 2 semanas
At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.
Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.
As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.
**Job Summary**:
We are seeking two new members for our Computer Software Validation (CSV) group within the Laboratory Operational Support Group located in Elphinstone, Tranent.
Duties and responsibilities include:
- Manage the full lifecycle of validation projects including the installation, system configuration and commissioning of systems used in regulated environments.
- Write and assist in writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications
- Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate & site quality management system and current industry practices.
- Maintain appropriate validation documentation and files including the Master Validation Plan (MVP). Archive all validation documentation.
- Write or assist in the writing of SOPs for the Validation Department.
- Coordinate project meetings, steering committees, workshops and production of related documentation i.e. minutes of meetings, project plans etc.
- Train and coach staff in relation to validation projects as required.
- Manage cross functional teams involved in the validation project deliverables (e.g. Project Team, IT, Departmental Managers, vendors, etc).
- Provide project updates and input into established project documentation.
- Effectively communicate project expectations to team members and stakeholders in a timely and clear manner.
- Assist other departments in response to their validation requirements as required.
- Report any non
- compliances of Quality Management System with respect to validation to the Senior Management.
- Identify plan and schedule project timelines and milestones using appropriate tools.
- Develop and implement solutions to validation issues.
- Present validation systems program during internal and external audits.
- Perform all other related duties as assigned
The following are minimum requirements related to the position:
- Some experience and/or interest in CSV
- Good organisational skills and the ability to run meetings effectively
- A proven record in working within and across teams effectively
The pay scale for these roles are £29,441.12 to Non graded
**Benefits**:
**What you can expect from us**:
- World Class Training and a structured progression scheme
- Competitive salary
- Private Health Care
- Subsidized electric car scheme open to all employees
- Pension scheme including 8% employer contribution
- Personal life insurance equivalent to 6 times your annual salary
- Employee discount scheme - discounts across hundreds of retailers
- Paid opportunity to volunteer for one day each year
- Free onsite fitness suite and fitness lessons
- Discounted staff canteen
- Free onsite parking
**About Corporate Functions**
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
