Description
Pioneering drug manufacturing facility based in the South East have a contract requirement for an experienced QAV ENGINEER.Working within a Pharmaceutical manufacturing facility our client is looking to increase capacity due to product demand hence the facility upgrade and expansion projects.
Quanta are looking for an experienced QA Validation Engineer to review the validation documentation ensuring compliance to cGMP.
Duties will involve:
- Prepare/review key validation documents including; validation plans, risk assessments and traceability matrices.
- Support projects to ensure validation documents (eg DQ, IQ, OQ, PQ, PV, 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.
- Possible execution of protocols as required by projects.
- Witness execution testing as required - Periodic reviews, Equipment history files, Documentation management, Change controls.
- 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, minimum of 1 year.
- Knowledge of Quality Systems including technical investigations (complaints, OOS, deviations, failure investigations, validation, etc.) and auditing.
- Excellent interpersonal skills and the ability to work as part of a team or independently to agreed deadlines.
- Excellent attention to detail.