Validation Analyst - UK - Home Based

Requisition Number: 5798

Position Title: Validation Analyst, Clinical Systems

External Description:

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. 

 

What a Senior Validation Analyst does at Worldwide

To co-ordinate and perform processes associated with the validation and maintenance of systems used to support the business process of WCT and representing WCT at sponsor and regulatory audits.

 

What you will do

• Responsible for overseeing the validated status of WCT systems.
• Responsible for the authoring of validation documentation.
• To be responsible for developing validation strategies for new, proposed, or modified systems.
• To assist in training and mentoring Validation team members in the technical competencies of validation and the authoring of validation deliverables.
• Responsible for the cataloguing and tracking of project specific validation documentation.
• To assist in the creation of style guides and templates used in validation packs.
• Responsible for preparing materials ready for WCT audits.
• To assist in the review of existing approaches to the SDLC with a view to improving procedures.

 

What you will bring to the role

• Self-motivated individual who can positively contribute to a team environment.
• Excellent interpersonal, verbal and written communication skills.
• Ability to handle and lead several highly complex projects simultaneously.
• Excellent ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning.
• Able to adjust to new, different or changing requirements and is also able to work to tight deadlines.
• Be able to demonstrate particular attention to detail and possess the ability to multitask.
• Be able to create and deliver training materials on the subject of validation to use within WCT.
• Experience and knowledge of the Validation Analyst.

 

Your experience

• Experience of Microsoft Word to create documentation templates (inc. Macros).
• Experience of document authorship and control
• Substantial relevant pharmaceutical industry, CRO, Clinical or Medical experience.
• Demonstrable experience of validation processes.
• At least 5 years experience of working within organisations employing GAMP, GxP, ISO standards.
• Demonstrable experience of creating and maintaining training materials and delivering training.
• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience.

 

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers. 

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers! 

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Employment Type: Regular

Community / Marketing Title: Validation Analyst - UK - Home Based

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: London, GB

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