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 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).
· Experience in Sample Management is preferred.
· 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
Additional Information
* In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
* Please note there is no relocation support available for this position
How to apply
* Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here
Quality Assurance and Control