IO Quality Compliance Operations Specialist

Pfizer Inc.

Remote, Hungary

Job posting number: #7136069 (Ref:pf-4881169)

Posted: March 24, 2023

Application Deadline: Open Until Filled

Job Description

Why Patients Need You

Everything 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 Achieve

  • The International Operations (IO) Quality Compliance Operations Specialist ensures that a compliant and robust quality management system is implemented, adhered to and maintained in support of GxP 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 Pfizer’s 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 COVID vaccine customers
  • 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

Qualifications

Must-Have

  • BSc in nature or medical sciences or engineering with relevant 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: Flexible

Closing date for applications is April 6, 2023
Please send resume in English.

#LI-PFE

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.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

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.

Quality Assurance and Control

#LI-Remote #LI-PFE


Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.


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More Info

Job posting number:#7136069 (Ref:pf-4881169)
Application Deadline:Open Until Filled
Employer Location:Pfizer Inc.
New York,New York
United States
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