Csv Compliance Specialist

North Wales  ‐ Onsite
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Keywords

Description

A global biotechnology organisation requires a Computerised Systems Compliance Specialist (with a strong QA background) for a 9 month contract position based in North Wales.

Role Description:

*Provide guidance and quality oversight for computerised systems compliance in all GxP areas.
*Support computerised system upgrades, projects, investigations and compliance improvements.
*Ensure global and local policies and procedures are adhered to on-site.
*Provide expertise, consultancy and where appropriate lead computerised systems compliance activities.
*Develop training packages as and when required to develop site understanding of computerised systems requirements.
*Integrate and interact across all relevant functions including Qualification, Maintenance, Project Engineering, Global Informatics, Global Quality, Production, QA/QC and Supply Chain to ensure site computerised systems are designed, operated and maintained in accordance with current EU/US FDA cGMP requirements through a lifecycle system.
*Participate and where appropriate lead internal quality audits, as and when required, in the area of computerised systems compliance.
*Provide quality oversight, ensuring that procedures and ways of working:
*Address requirements
*Reflect best practices
*Apply appropriate risk management

Minimum Requirements:

*Educated to degree level in a scientific discipline and / or information technology / computerised systems discipline.
*Good command of the English language. French or other European languages would be beneficial.
*Minimum of five years` of experience within the Pharmaceutical Industry in a Computerised Systems Compliance / Validation role.
*Strong Quality background.
*Experience of CSV, remediation activities and a practical application of EU GMP Annex 11 / 21 CFR Part 11 (essential).
*Experience of working with networked computerised systems across local and wide area network (essential).
*Project management skills.
*Excellent team working skills.
*Excellent organisational skills.
*Cultural awareness.
*Attention to detail and analytical ability.
*Excellent interpersonal and communication skills.
*Professional written and presentation skills with good concern for impact.
*Communication dimensions will typically span from computerised systems users and operatives to local and Corporate executives.
*Strategic influence and enable decision making at executive level.

Please apply now for more information!
Start date
n.a
From
Quanta Consultancy Services
Published at
27.02.2013
Contact person:
Lee Mitchell
Project ID:
496341
Contract type
Freelance
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