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Quality Operations Lead

Premium Job From Real Staffing
Recruiter: Real Staffing
Listed on: 24th January
Location: Dublin
Salary/Rate: £56000 - £57000
Type: Contract
Start Date: ASAP

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I'm currently recruiting for this excellent role with a Dublin based pharmaceutical. This is a highly sought after company where you would be working as part of a top class QA team. This role serves as the primary quality release officer prior to QP Certification. Responsibilities include:SAP QM user for Europe.Monitor SAP and add batches to the Batch Register as required.Following QP Certification, complete UD in SAPCollation of documentation required to support QP certification in EuropeBatch Review - cross functional training on full batch review process, back-up in Dublin officeMonitor status of batch release to ensure all completed in a timely manner.Generate release packs, perform initial review and forward packs as relevant.Identify batches 'on hold' and ensure someone has been allocated responsibility to ensure resolution of associated issues.Scan and file batch release documentation as applicable.Completes Results Recording for all non-EU batches.Communication with pre-wholesalers including notification of batch release and confirmation of status update. Quality Management SystemInitiates deviations and change controls associated with batches for release to support QP Certification. Routine meeting for record closure and KPIs.Provides oversight of complaints relevant to batch release activities communicate with the relevant CMOs and ensure reports received on time.Ensures stability programme is carried out in accordance with approved protocols and registered details. Ensure copies of all stability protocols have been received from each CMO in accordance with the annual stability programmes.Requests stability reports on a monthly basis and perform initial review to ensure results meet specification.Monitors annual Product Quality Review schedule and communicate with relevant CMO to ensure documentation is received on time. Initiate additional documentation generated by the Marketing Authorisation Holder for each Product Quality Review.Ensures training is up to date and access governance for applicable document system(s) is in place.Prepares and attend Dublin QMR as per schedule.Product Compliance Summary (PCSs) - Back-up for PCS Process Owner, populate packaging sections, check alignment with change controls. Other responsibilities Serves as the primary contact for Global Regulatory teams' requests for information from CMOs.Serves as secondary support for other quality systems roles based in the Dublin office.Manages other activities required to support the Dublin office, such as purchase orders (POs) required to support MIA, Health & Safety, contractors, maintenance of the office.Generates data and create summary tables and graphs associated with Europe's Key Performance Indicators.Attends quality operational and compliance meetings and issues minutes and action lists when requested.Responsible for the daily management of post received at Europe's office.If you are interested in this role, or in other contract QA/QP roles, please feel free to reach out to connect with Julieann Fitzpatrick on LinkedIn and I would be happy to set up a confidential chatPlease 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