Job Description

QA Validation Specialist - Kerry

The successful QA Validation Specialist will be qualified with a BSc or equivalent academic qualifications with previous Industrial/pharmaceutical experience an advantage.

Strong reviewing skills and attention to detail to ensure right first time with GxP Validation or validation governance experience an advantage. GxP Change Control experience also an advantage.

Duties:

• Involvement in the development, improvement and control of GxP validation activities. QA Final approval compliance governance function. Reviewing and approving validation documentation, e.g. User Requirement Specifications, Validation Plans, OQ, PQ, Validation Protocols/ Reports, Qualification Data etc.
• Ensuring compliance with AICL(KP) procedures and regulatory requirements.
• Participation in project teams to advise and assist in ensuring that validation documentation is written and executed in accordance with internal validation procedures, policies and adheres to the principles of cGxP.
• Familiarisation with developments, evolving regulatory requirements and innovations in validation requirements.
• QA Management of site GxP change control processes, ensuring maintenance of GxP compliance, procedural compliance and of the validated state.
• QA Management of Computerised System Periodic Reviews to ensure maintenance of the validated state.
• Generation of the site Product Quality Reviews for GxP change control activities.
• Biannual Trend Review of GxP site change controls.

Arcadis is an Equal Opportunities Employer.

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