Senior Validation Officer

Senior Validation Officer – Cambridgeshire – Competitive benefits and salary depending on skills and experience

The Senior Validation Officer will be responsible for qualification and validation activities in accordance with corporate standards, site procedures, User requirements, equipment specifications and regulatory guidelines thereby maintaining cGMP for the site.

KEY RESPONSIBILITIES:

* Prepare, execute and report validation documentation.
* Support and qualify as necessary, coldchain projects, facilities, large -scale API manufacturing plant, production systems and processes.
* As the Validation Subject Matter Expert, to evaluate and advise on CHANGE as applied to equipment and processes and be responsible for associated revalidation project.
* Participate in HAZOP reviews in relation to assigned validation projects.
* Perform Quality Reviews on plant and equipment in support of Requalification as required.
* Ensure manufacturing Process Validation projects are executed and reported effectively by the various responsible departments involved.

The successful candidate will have:

* Background in engineering and/or commissioning with experience of working in a large-scale API manufacturing site and familiar with commissioning and validation through an integrated approach (ICV).
* Demonstrated ability to successfully facilitate projects.
* Demonstrated knowledge of working within a Quality Management System and cGMP.
* Familiar with Secondary Operations activities such as packaging and labelling equipment and its qualification/validation requirements.
* Familiar with the various tools and processes for performing Risk Assessments.