Qualified Person


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

24th June 2022

Location

Waterford

Salary/Rate

£76806 - £85842

Type

Permanent

Start Date

asap

This job has now expired please search on the home page to find live IT Jobs.

My client is a well-established and popular pharmaceutical company based in Waterford, with a reputation as a great place to work.We are currently looking for a permanent Qualified Person to join their Quality Department.As Qualified Person, you will be responsible for ensuring that all products being released for commercial or for clinical trial purposes comply with the requirements of the Marketing Authorisation, or Clinical Trial Authorisation, have been manufactured according to the principles of GMP as per Directive 2003/94/EC. Responsibilities of the QP;To ensure that all processes/stages in the manufacture, testing and packaging of products have been adhered to according to the cGMP/cGLP/Regulatory and licence requirementsTo ensure all batch related documentation is completed and endorsed by relevant trained personnelTo review and release batches according to shipment schedule ensuring all batches are in compliance with regulatory requirementsOutlining batch investigation requirements and responsibilitiesAny planned changes or deviations in manufacturing or QC have been notified in accordance with a well-defined reporting system before any product is released. Such changes may need notification to and approval by the HPRAEnsure the principal manufacturing and testing processes have been validatedEducation & Experience Required;Qualified Pharmacist or Graduate of Diploma in Pharmaceutical Manufacturing Technology or equivalent "Qualified Person" status as defined by E.C. Directive 2001/83Proven experience within the Pharmaceutical industry in a leading QA/QC/Compliance roleExcellent knowledge of regulations and sources of regulatory information To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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