QC Analyst

2 weeks ago


Dublin, Dublin City, Ireland Cpl Full time

Cpl in partnership are seeking a QC Analyst - Sample Management to join the team for a contingent fixed term 11 month contract at their state of the art plant in Grange Castle, Dublin.

Quality Control Sample Management Analyst

Job Responsibilities:


• Routinely receive manufacturing test samples and distribute to the appropriate analytical laboratories.


• Oversee and maintain appropriate procedures to ensure chain of custody for QC samples is maintained.


• Manage the incoming shipment processes from external sites, verification of sample inventory, processing of samples and distribution to QC test laboratories.


• Shipment of Drug Product and associated bulk Drug Substance regulatory samples to BOH sites.


• Management of stability sample processes including study enrolment, time-point pulls, sample shipment, and study disposal.


• Maintenance of the reserve program, including inspection of reserve and retention samples, documentation of inspection results, and maintenance of reserve / retention equipment.


• Reference material inventory management.


• Perform review and approval of QCSM standard operating procedures, sampling and analysis plans, and stability protocols to ensure compliance.


• Facilitate laboratory investigations and support associated product investigations.


• Support the preparation and review of QC APQR and periodic review reports.


• Partner closely and proactively engage with customers and key stakeholders to understand and deliver samples within specified turn-around times, participating in cross functional teams as required.


• Represent QCSM at product, technical and robustness team meetings and lead/drive associated deliverables.


• Contribute to the completion of complex projects, managing own time to meet agreed targets and developing plans for work activities on own projects within a team.


• Participate in new initiatives such as the 5S, Standard Work, Data Integrity and IMEX programs as they arise.


• Engage with the business to identify and define scope for continuous improvement, robustness, and Best Practice initiatives assisting with improving the efficiency of local and across site processes and procedures.


• Ensure compliance with cGMP, corporate standards / Pfizer Quality System (PQS), site policies / procedures, and regulatory requirements.


• Technical writing assignments such as SOPs, trend reports, risk assessments, laboratory investigations, and change controls.


• Assist in the maintenance and development of training programs and perform training of other analysts. Report and document any non-conformances to the QC Supervisor.

Education/Experience:

To be successful in this role the following are prerequisites to application:


• Third level Qualification in Science, Engineering or related Technical field required.


• Minimum of 4 years' + experience in a Quality Control or Quality Assurance position. Experience in Sample Management, Stability Management, Product Inspections, and Lab systems (LIMS, SAP, Trackwise, PDOCs) an advantage.


• Excellent communication and interpersonal skills.


• Demonstrated capabilities and experience collaborating and working effectively in team settings, frequently in virtual teams; embrace diversity; influence stakeholders and build business partnerships to deliver results.


• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment. Excellent communication and interpersonal skills


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