CSV Specialist (Ref: 42758)

Salary / Rate:

GBP 10.00-20.00 

Location:

North Wales 

Rate:

Yearly 

Job Type:

Permanent 

Sector:

Validation 

Date Posted:

16/05/2008 

Reference:

42758 

Our client is a global pharmaceutical company and they are currently looking for a CSV specialist on a permanent basis for their site in North Wales.

Primary Purpose of Position:

Ensure an integrated approach to capital projects delivers qualified Facilities Utilities and Equipment compliant with EU and FDA regulation. Also to maintain existing equipment in a qualified state.

Main Duties to be performed:

Lead agreed qualification activities in accordance with Site Procedures, and to industry best practice

Plan, resource and execute Qualification activities to deliver compliance in line with business needs.

Review, develop and maintain procedures for Qualification in line with industry best practise.

Work as part of a multi disciplined and cross organisational project team to meet business objectives.

Specifics of Position

The job holder will provide Qualification expertise for routine activities and projects across MSO Wrexham.

The job holder needs to be competent in the generation and review of qualification documentation to ensure an appropriate standard, suitable for supporting regulatory inspection.

The job holder is expected to be competent and experienced in regulatory audit participation.

The job holder should be capable of operating effectively in complex project organisations under potentially conflicting priorities. Line management skills together with a range of people influencing skills is required to ensure adequate qualification standards are achieved within a given project.

A sound understanding of Computerised Systems Validation is required, along with experience in implementing pragmatic CSV solutions. The role will be responsible for delivering CSV learning within Qualification.

The job holder should have experience with primary pharmaceutical manufacture and associated technology. The role requires this knowledge to be used for technical input into resolving Quality investigations (typically CAPA, Unplanned Event Reporting and Qualification Discrepancies resolution).

The job holder will be responsible for managing and supporting execution of all qualification and requalification activities within the Primary Manufacturing Facility.

Apply online for immediate consideration