Validation Lead, Cork

14 Oct 2020
11 Nov 2020
John Finn
Job Type

I have a good opportunity for an experienced Validation Lead, for a Pharmaceutical, Medical Devices and Diagnostics company based in Cork.

There is an excellent salary on offer, please contact John Finn in Manpower Group for details.


Job Description and overview:


*Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems
*Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
*Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs
*Coordinate alignment of systems users from various company groups on validation and qualification documentation
*Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
*Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
*Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.


Personal Skills and Experience:

*5 years plus of Lab Systems validation experience is required.
*Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
*Understanding of Data Integrity concepts is required
*Excellent communication and written skills required

If you are interested in this Validation Lead, Cork role please do apply through the site with your CV or contact John Finn directly at ManpowerGroup for more information and a for a confidential call: 01 645 5222, Mobile: 087 621 4254 (Outside normal business hours)

Validation, Validation Lead, Lab Systems validation, Laboratory Systems, COTS, Validation Specialist, LabX, Mettler Toledo, titrators, pH meters, UV Vis spectrophotometers, density and refractometers, melting point systems, and automation solutions.

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