Supply Operations Quality Specialist

We're in relentless pursuit of breakthroughs that change patients' lives.We innovate every day to make the world a healthier place.To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.The SOQ teamare the main point of contact for the investigation and resolution of all product quality/compliance issues discovered or originating in the Ireland Pfizer Country Office (PCO) and for interacting with the local regulatory authorities (HPRA) and relevant stakeholders (such as Regulatory Affairs, Medical) and Pfizer Global Supply (PGS) on such issues.The Supply Quality Operations (SOQ) Specialistplays a critical role in supporting the Responsible Person (RP) for Good Distribution Practice (GDP) by helping to establish and sustain a robust Product Quality System and a strong Quality Culture within the PCO.This ensures that all products, whether physically or financially managed by the PCO, comply fully with applicable GDP/GMP requirements.The SOQ Specialist is responsible for operating within and supporting all aspects of the SOQ Quality Management System (QMS).This includes ensuring that key elements of the QMS are implemented, documented, and maintained in accordance with Pfizer Corporate policies and relevant regulatory requirements.Additionally, the specialist will support and participate in both Pfizer corporate and self-internal audits, as well as local regulatory inspections conducted by the HPRA.Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients.Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first.Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.What You Will AchieveManage moderately complex projects by planning and prioritising short-term activities efficiently.Lead quality investigations and execute Corrective & Preventive Actions (CAPA) to resolve and prevent compliance concerns.Liaise with stakeholders to address product quality matters and uphold compliance with GMP/GDP standards.Support the RP for GDP in the co-ordination of product quality recalls and/or market actions.Oversee complaint handling, ensuring alignment with Pfizer policies, GMP regulations, and thorough investigation/reporting of suspected falsified medicines.Assist in the preparation and coordination of Regulatory Authority and Pfizer inspections, including audit CAPA support.Act as Quality Subject Matter Expert (SME) for new product launches, expansions, and discontinuations within Ireland.Serve as SME for local Standard Operating Procedures (SOPs), initiating updates and overseeing periodic reviews.Generate and analyse quality KPIs, highlighting significant trends and supporting regular management reviews.Coordinate local GDP product release activities, collaborating with the EU release Hub, Supply Chain, and Regulatory teams.Act as training SME for the Pfizer country office responsible for generation and rollout of training for GDP processes and procedures.Support qualification and quality oversight of Pfizer Vendors and Logistics Service Providers (LSP).Here Is What You NeedBachelor's degree in biology, chemistry, or a related technical discipline.At least 4 years of experience within the pharmaceutical industry, preferably in Quality Assurance, Quality Control, or a technical function.Comprehensive understanding of regulatory GDP/GMP compliance associated with the manufacture and distribution of medicinal products.Strong critical thinking abilities and a proactive mindset.Excellent organisational, collaboration, and communication skills, both written and verbal.Preferred RequirementsProficiency with Microsoft Office applications and enterprise systems such as Trackwise and Vault.Demonstrated ability to work effectively under pressure and meet deadlines.Experience influencing and negotiating with stakeholders.Background in conducting internal audits and supporting regulatory inspections.Eligibility to act as Deputy Responsible Person.Work Location Assignment: HybridMake a difference todayAll suitable candidates should apply through the link with CV provided.We are looking forward to hearing from youIn order to be considered for this position you need to be legally eligible to work in the EU.Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Due to the high volume of applications we will be contacting successful candidates only.Closing date for applications is October 12th ****.Additional InformationIn 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 positionHow to applyMake a difference today, all suitable candidates should apply with CV below.We are looking forward to hearing from youPurposeBreakthroughs 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.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.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 InclusionOur 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#J-*****-Ljbffr