Qualified Person page is loaded## Qualified Personlocations: Ireland - Dublin - Grange Castletime type: Voltijdsposted on: Vandaag geplaatstjob requisition id: *********Use Your Power for Purpose**Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients.
Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance.
Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.
**What You Will Achieve**In this role, you will:* Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work* Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations* Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications* Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management* Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills* Assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups* Support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs* Participate in internal cGMP audits, support regulatory inspections, perform disposition of clinical trial materials, and communicate with internal and external customers to resolve project-related issues* Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues**Here Is What You Need** (Minimum Requirements)* BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience* Substantial experience in pharmaceutical manufacturing and quality control* Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects* Knowledge of regulations related to vendor management programs and other industry quality systems* Strong critical thinking skills and a proactive approach* Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally* Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms**Bonus Points If You Have** (Preferred Requirements)* Experience in Quality Systems in pharmaceutical, medical device, or combination product industry* Knowledge or exposure to data science* Strong leadership and team management skills* Ability to work under pressure and meet tight deadlines* Ability to influence and negotiate with stakeholders* Experience in conducting internal audits and supporting regulatory inspections Work Location Assignment: Hybrid **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 StrategyOne 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 OpportunityWe 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!
Quality Assurance and Control
#J-*****-Ljbffr