IO Quality Compliance Operations Sr Specialist

Job Description

Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will AchieveThe International Operations (IO) Quality Compliance Operations (Sr) Specialist ensures that a compliant and robust quality management system is implemented, adhered to and maintained in support of GDP Operations. The incumbent will have significant interactions with many internal business and quality organizations. The Quality Specialist interacts with Intercompany Quality teams, Market quality teams within Supply Chain & External Supply Quality (SCESQ) and key stakeholders including quality teams at Pfizer Country Offices, Customer Services, Customs and applicable business support functions to ensure that all Pfizer products supplied to distributors meet all requirements regarding: regulatory, quality, safety and security requirements according to Board of Health (BoH) and Pfizers expectations.As a Quality Specialist, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It

• Responsible for customer and supplier qualification process and management/improvement of this process
• Responsible for qualification of customers/suppliers
• Preparation and presentation of KPI metrics for customer and supplier qualification activities
• Monitors compliance activities to ensure current regulatory requirements are met
• Preparation for and attendance on Inspections by Board of Health and internal audit
• Development and maintenance of consistent quality culture
• Support the investigation and resolution of all product quality system and GDP related issues discovered
• Ensures quality support to any project in case of need
• Support to implement proper inspection/audit response with defined Corrective Actions/Preventive Actions and Commitments to GDP inspections and audit findings
• Support to ensures that the electronic solutions and systems are fit for purpose
• Participates in and in case of request leads the identification and implementation of continuous improvement projects
• Supports the revision, evaluation of the investigations and present formal notifications of significant issues to senior management and Quality Review Teams

QualificationsMust-Have

• BSc in nature or medical sciences or engineering with relevant experience
• Customer/supplier qualification experience
• Good skills on Microsoft office tools (Word, Excel and PowerPoint)
• Fluent English and Hungarian language communication verbal and written
• Excellent communication and interpersonal skills
• Organizational skills to manage different tasks in a timely and thorough manner
• Structured way of working and consensus building ability
• Proactive approach and strong critical thinking skills
• Sound and effective quality decision making under pressure
• Self-motivated and comfortable with working independently
• Must be able to work in a team environment within own team and interdepartmental teams

Nice-to-Have

• MSc / Postgraduate and relevant pharmaceutical experience
• Relevant experience within Quality / Compliance area is preferable
• Knowledge of current Good Distribution Practices regulations and standards
• Experience in Quality administered systems
• SAP knowledge is a plus

Work Location Assignment:RemotePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control#LI-Remote #LI-PFE

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About Company

Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German immigrants, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891).
Pfizer develops and produces medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology. The company has several blockbuster drugs or products that each generate more than US$1 billion in annual revenues.In 2020, 52% of the companys revenues came from the United States, 6% came from each of China and Japan, and 36% came from other countries