QA Validation Specialist

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My client, an exciting Pharmaceuticals start up, are looking for a QA validation specialist to join their growing team in Tipperary. You would be joining this company at an interesting time of growth, with a product going commercial this year, and further products in clinical trials.

This is a 12 month hourly rate opportunity for a QA validation specialist, based in Tipperary, Munster. You will provide quality support to production activities including batch review, sampling, cleaning validation, equipment qualification, doc review and audits.

Essential Duties

Support to batch manufacture including line sign-off prior to start of batch manufacture, performing in process checks during batch manufacture.Perform routine review of documentation such as Batch records, logbooks, forms, protocols, reports, COAs, etc. generated to support commercial and development batches for accuracy, completeness, and compliance to GMP and procedural requirements.Review of Standard Operation Procedures for manufacturing operations and cleaning.Participate in any investigation related to manufacturing.Prepare Standard Operating Procedures, investigations, reports and forms as required.Preparation, execution and coordination of Cleaning Development / Verification / Validation study protocols and reports;Preparation, execution and support of studies / risk assessments / investigations related to Cleaning;Perform swab sampling (bioburden and chemical)Review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilitiesReview and approval of calibration and PM activities (e.g. schedules) and Work ordersPerform internal / process audits. Monitoring of GMP compliance during production activitiesMonitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrencesTo apply for this role, you should have at least 2-3 years experience in a Pharmaceuticals GMP environment and be available to work on site in the Tipperary area.

If you would like to learn more about this exciting opportunity, please respond to this adverts, and I will reach out to discuss in more detail.

*Please note, in order to be eligible for this role, you must hold a valid EU passport, stamp4, or Stamp1g*Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales