QAV Engineer

QAV Engineer - Contract - Kent

Our client, an innovative pharmaceutical organisation responsible for manufacturing unique therapeutic products within the EU and US are currently entering a period of exciting growth. Located within the South-East of the UK and within easy reach of major airports.

With a recent successful audit result and a blockbuster drug in development/preparation for release they are entering a period of significant activity and capital project spend.

They are seeking the expertise of a QAV Engineer (Quality Assurance and Validation) to support the next phase of their project.

Responsibilities:

• Capable of early stage set up of QAV systems
• Act on behalf of QA interfacing with the project delivery team
• Prepare/review key validation documents including; validation plans, risk assessments and traceability matrices
• Support projects to ensure validation documents (e.g. DQ, IQ, OQ, PQ, PV, URS’s, traceability matrices and risk assessments) are produced at the appropriate time to maintain compliance and avoid delays in projects
• Ensure the documents are of an appropriate standard to demonstrate compliance and are aligned to developing industry trends in validation strategies
• Act as validation approval on commissioning and validation documentation
• Execute protocols as required by projects
• Witness execution testing as required
• Periodic reviews, equipment history files, documentation management, change controls

Experience:

• Education to degree standard, preferably in scientific or quality systems discipline or experience from vocational training
• Relevant experience in a QA validation role in the pharmaceutical industry
• Engineering focused
• Secondary manufacturing experience
• Ideally project based experience with exposure to primary manufacturing operations (extraction) as well as Drug Product operations – filling / packaging line experience
• Knowledge of Quality Systems including technical investigations (complaints, OOS, deviations, failure investigations, validation, etc.) and auditing

If you are interested in this role or would like to learn more, please apply today!

The candidate must have the rights to work in the location stated in the job advert.

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