Quality Compliance Officer


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

5th July 2021

Location

Dublin

Salary/Rate

£31626 - £40662

Type

Permanent

Start Date

ASAP

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

My client, a pharmaceutical company based in Dublin are looking for a Quality Compliance Officer to join their Quality Department.Reporting into the Compliance Manager, the Quality Compliance Officer will be responsible for completion of Product quality review, data tracking and trending and reviewing Third Party manufacturing activities for compliance to the MA.As Quality Compliance Officer, you will be responsible for;Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives for assigned productsReview of internal documentation to ensure compliance with license details and relevant guidelines and directivesInitiate and investigate non-conformances/Process investigations as required where issues detected. Track and investigate any assigned investigations and complete CAPA actions to agreed timeframesReview and approval of Third Party CMO Master Batch RecordsComplete Annual compliance reviews of Third Party CMOs manufacturing process, specifications, test methods, GMP licence, and validation status, Stability reporting and packaging specifications for compliance to the MAReview change control for assigned products and bring changes to the change review board (CRB) as necessaryTrack and review CMO Product Quality Reports (PQRs) for assigned products and ensure that these are consistently completed fully and on-timeEducation & Experience;Third Level qualification preferably in a scientific disciplineA Working knowledge of quality systems requirements, HPRA, MHRA, EU regulations and ICH guidelines as they relate to Quality AssuranceExperience and knowledge of Good manufacturing practises and associated regulations Great salary and benefits package on offer with this role 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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