QA Validation Lead

  • Sligo
  • Permanent
  • JO-1906-64569_1564583570

Summary

QA Validation Lead

Key Responsibilities:

· Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.

· Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.

· Generation/maintenance of the Validation Master Plans.

· Generation/maintenance of Project Validation Plans.

· Generation of validation protocols and final reports to cGMP standard.

· Review / approval of all protocols and final reports.

· Management of validation change control process.

Requirements:

· 3rd level qualification in engineering or scientific discipline.

· A minimum of 5 years experience in a cGMP regulated environment, with validation activities demonstrated successfully.

· People Management experience is desirable

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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The Life Science Specialists

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