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Qualification and Validation Specialist

The Gxp Recruitment Company

Grangemouth

Permanent

FK38JE

Posted: 18/09/2022

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GxP Recruitment invites applications on behalf of our biopharmaceutical client in Grangemouth where a brand-new position has now arisen for an experience Qualification and Validation Specialist to join their team on a permanent basis.

This is a full-time, site-based role.

Key duties include:

1. Provision of support and guidance to validation projects. This includes:

* Establishing project plans and milestones in conjunction with project teams to meet the customer’s needs.

* Facilitation of validation projects.

* Provision of validation expertise, advice, and guidance to the project team to ensure compliance with site policy and procedures.

* Authoring of validation documents in conjunction with project teams and in compliance with relevant SOPs. The technical content of the documents is provided by the system owners and system experts.

* Facilitation of the review and approval of validation documents.

* Practical support during protocol execution where required and appropriate.

1. Provision of practical support to Periodic Review activities.

2. Maintenance of the Inventory and Schedule with information provided by the validation practitioners.

3. Contribution to the development, implementation, maintenance and continuous improvement of validation policies, procedures, good practice example documents, templates and working practices.

4. Generation of training packages and delivery of training on validation related topics.

* Maintain and develop knowledge of current regulatory expectations and industry best practices with respect to validation.

The ideal candidate:

* Qualified in a technical or scientific area relevant to this role, either formal education, qualified by experience or a combination of both

* Technical knowledge of qualification and validation systems

* Excellent written and verbal communication

* Presentation and training skills

* An excellent team player

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