Job Purpose:  

Responsibility for carrying out sample management tasks pertaining to GC / external site manufactured products, regulatory reserve samples, stability samples and Board of Health samples. 

Job Responsibilities: 

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

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

Management of ad-hoc sample request procedure and distribution of the associated samples to the appropriate analytical laboratories. 

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

Receipt and management of GC manufactured, and external site manufactured regulatory samples. 

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. 

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

Support the QCSM investigation process by providing accurate and concise information in a timely manner and raising investigations in QTS. and eQMS. 

Participate in cross functional teams as required to provide support on, and resolution of, sample management and reserve requirements. 

Partner closely with customers and stakeholders to understand and deliver samples within specified turn-around times and escalate when necessary. 

Proactive engagement with customers and key stakeholders. 

Maintain the QCSM laboratories in a state of audit readiness at all times. 

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

Participate in and drive the continuous improvement of all aspects of the QCSM group. 

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. 

Education/Experience 

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

Third level Qualification in Science, Engineering or equivalent is preferred, though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel). 

Excellent communication and interpersonal skills. 

An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment. 

Work Location Assignment: On Premise 

  
Work Location Assignment: On Premise