Medical/Pharmaceutical/Scientific

Senior Quality Manager – CSV (Homebased in Europe)

Full Time Permanent

UK Job Network

This role is responsible for providing Quality oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of industry regulations (21 CFR Part11 and EU Annex11) and standards (GAMP). Also, to conduct internal and external (third-party) audits of Computerised Systems and to provide independent and objective fact based opinions and to assure compliance with applicable PrimeVigilance´s and/or Client´s procedures and local and global regulatory requirements as well as contractual agreements.

* Provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations etc.

* Reviews and/or approves the key validation deliverables of Computerized Systems as a part of the support to the GxP projects.

* Facilitate and perform Quality Risk Assessments on all IT infrastructure, applications and support processes.

* Conduct Computer Systems Validation (CSV) audits initiated by PrimeVigilance, according to the agreed Audit Programme including effective management of pre-audit activities as instructed by Line Management

* Audit types include:

* Audits of PrimeVigilance’s Partners and Vendors/Service Providers;

* Internal Audits of Business Computer Systems and IT Processes

* Audits of Third Parties on behalf of Clients on Computer Systems

* Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines

* Participate in data integrity and data governance forums as CSV subject matter expert

* Reviews and approves all CSV related CAPA plans from internal audits and client audits within timelines mandated by PrimeVigilance procedures.

* Assists in trending CSV related audit and CAPA data in order to identify actionable trends and risk areas

* Validation

* Act as liaison between IT and QA to ensure that all computerised systems are in accordance with industry regulations (21 CFR Part11 and EU Annex11) and standards (GAMP) for computerised systems

* Continuous improvement and further development of companies CSV procedures and strategy

* Ensure proper execution of the qualification and validation activities with respect of the validation methodology

* Review and approve CSV specific validation documents/deliverables

* Review and approve CSV specific SOP’s and Template

* Coach the User, Technical and other QA departments in the validation methodology applied to automated and computerized systems

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