Are you ready to be part of an international, innovative, world-class pharmaceutical company? Or an organization committed to putting patients first? Guided by our values: Courage, Joy, Equity and Excellence? Where you can look back at the end of the working day and say 'I made a difference to patients' lives today'
Quality Operations BeLux Specialist
Location: Brussels Pfizer Country Office (Boulevard de la Plaine 17, Ixelles) – Hybrid home/site arrangement. Occasional travel to the office in the Netherlands may be required.
About the role
You will be a member of Pfizer's dedicated and highly effective Quality Operations team of the Belgian affiliate. In this function, you will be responsible for QA activities to support the Product Quality Management System for products marketed in Belgium and Luxembourg.
Your proactive problem solving approach will ensure that all quality operations are handled as per the European Commission Guidelines on Good Distribution Practice (GDP), Belgian regulations and company policies/procedures.
You will maintain unified standard operating procedures and provide technical expertise to optimize existing processes. This role can grow into a back-up Responsible Person (RP) for distribution.
As a Quality Operations 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 establishing good collaboration with colleagues from other markets (BeNeLux and Central Eastern Europe region).
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
Main responsibilities
* Participates in the supervision of processes related to GDP (drug supply, stock management, stock availability, customer management, logistics complaint handling, temperature monitoring and transport of products, product disposition) and GMP (review documentation related to the relabeling/repackaging operations).
* Maintaining Quality Management System (QMS) as for example local batch releases, revision of Standard Operating Procedures (SOP's), training facilitation, quality complaints handling, internal audits, change controls, vendor quality management and more.
* Assists with the investigation and resolution of quality issues discovered or originating in the Pfizer Country Office (PCO), such as product defects/damages, artwork and labeling errors, counterfeits, temperature excursions during storage/transport or issues with contract manufacturers or logistics service providers.
* Defines and implements appropriate Corrective and Preventive Actions (CAPA's).
* Compiles quality Key Performance Indicators (KPI's). Analyses data to identify trends and reports relevant information to the BeLux Market Lead.
* Supports the preparation and coordination of Regulatory Agency inspections and internal Pfizer audits to ensure compliance with GMP/GDP practices.
* Active engagement in quality projects with focus on Continuous Improvement.
* Interacting with the relevant local stakeholders such as Regulatory Affairs, Medical, Safety, Global Supply Chain, Business Units and enhancing the Quality Culture.
About you
Must-Have
* Industrial Pharmacy degree or equivalent education as per the Royal Decree for Medicines for Human Use (dated 14 December 2006) Article 95 § 2.
* Entry-level job, fresh graduates are also welcomed.
* Good knowledge and understanding of GMP and GDP, including principles of Good Documentation Practices and Data Integrity.
* English, French and/or Dutch verbal and written with motivation to learn the other language.
* Proficiency in using System Application and Microsoft Word, Excel, Power Point, Visio.
Nice-to-Have
* Previous working experience in GDP or in Pharmaceutical Industry (Quality, Manufacturing or Regulatory role) is an asset.
Managerial skills
* Excellent organization skills and the ability to manage multiple priorities.
* Good collaboration, communication and interpersonal skills with local, regional and global colleagues.
* Makes sound and effective quality decisions under pressure, assesses risks through analysis of data.
* Have a continuous improvement mindset.
What do we offer?
Innovative company Pfizer has a pipeline full of innovative medicines for a variety of conditions. As a Pfizer colleague, you'll havethe opportunity to maximize the impact of medicines for patients in a variety of ways. In short, you make a real difference.
Development opportunities We are always looking for top talent. We believe you will never stop learning and there will always be a new opportunity for your development. That is why we have broad opportunities in the Dutch organization. There are regular opportunities for training or to gain experience in a different field or even advancement to an international position.
A culture where you can be yourself We are a large, international organization with people from all over the world. At Pfizer everyone should be able to be themselves, that's what we strive for and live by.
Work/life balance At Pfizer, we know that if you really want to make an impact on people's lives, it's important that your people are at their best. That's why we offer our colleagues good working conditions, such as an appropriate salary and opportunities to work from home. Working a lot of overtime is not the norm for us. We also believe that work and having fun should go hand in hand. That's why, for example, you can participate in all kinds of activities outside of work.
Are you interested?
Do you know enough and have you decided to respond? We are curious about you and invite you to submit your application via the apply button. You don't have to worry about a deadline to respond. We keep looking until we have found the right candidate for this position.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
We kindly ask you to provide your application documents in English.
Work Location Assignment: On Premise
Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is central to this story.
Pfizer has four offices in Belgium with which it supports its Belgian and international activities: 1) Anderlecht, where the Pfizer Clinical Research Unit is located. This is a fully equipped phase 1 research center. With that of New Haven (US), it is one of two Phase 1 Pfizer research centers in the world, 2) Elsene, the Belgian headquarters, 3) Puurs, Pfizer's production and packaging site, and 4) Zaventem, the international Pfizer's Logistics Center.
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Pfizer's aim is to provide equality of opportunity in the recruitment process by avoiding any bias or potential discrimination on any grounds including (but not limited to): sex, age, race, religion or belief, sexual orientation or disability. At Pfizer we are creating an organization and promoting a culture that respects each individual's unique character and life experiences and reflects the diversity of our society, customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported.
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