Senior Validation Specialist

Summary:

Senior Validation Specialist

The Role

Due to on-going expansion and operational developments, our client has a unique opportunity for a Senior Validation Specialist to join one of the world's largest global pharmaceutical companies. Reporting to the Engineering Manager, you will provide SME support and management of C&Q and Validation activities on projects in the Cork site in order to assist internal stakeholders to meet current cGMP regulatory requirements.

Responsibilities:

· Leading C&Q and Validation activities for the Cork site and maintain & improve the commissioning, qualification & validation systems within the company.

· Assist with risk assessments/change controls and deviations by providing input as a subject matter expert on behalf of validation.

· To lead and advise the validation of new/existing facilities, utilities, equipment and processes and liaise with production, QC and maintenance on qualification & validation scheduling.

· Generate, review or execution of VMP/DQ/FQ/IQ/OQ/PQ/ protocols/reports for equipment, facility, utility, process & computerised systems.

· Create/maintain site validation master plan or validation project plans as necessary and create/maintain validation/engineering department related SOPs and WI documents.

· Implementation of the Cleaning Validation program within the company and co-ordination of the annual re-qualification studies i.e. temperature mapping or air quality testing executed by external contractors.

Requirements

· Minimum qualification of a bachelor's degree in a scientific/technical discipline required.

· 5 - 8 years' experience working with validation and qualification projects within GMP regulated environments.

· Experience in contributing to GMP management systems such as change control/deviations/risk assessments.

· Understanding of various validation concepts i.e. thermal/sterilization/facility/cleaning/equipment etc.

· Strong understanding of API manufacturing.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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