BD (Becton, Dickinson and Company) Pharma QA specialist in Erembodegem, Belgium
Job Description Summary
• Ensure that the products sold in the countries covered by the infection prevention business meet pharmaceutical Quality and Regulatory requirements.
• Assist Regional Qualify persons to ensure batch release in a timely manner
Pharma QA Specialist
Erembodegem - Dorp /Belgium
A superb, wide-ranging Pharma QA Specialist career development role with BD, a global leader in Medical Technology.
BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey to ‘helping all people live healthy lives’.
As Pharma QA Specialist, you’ll have to ensure that the products sold in the countries covered by the infection prevention business meet pharmaceutical Quality and Regulatory requirements and assist Regional Qualify persons to ensure batch release in a timely manner
Create and maintain Quality Systems in compliance with pharmaceutical regulations for the key entities supporting BD pharmaceutical Quality System in support of the IP platform in Europe as well as other OUS locations with a specific focus on the regional pharmaceutical importation and release Quality system.
Liaise with Regulatory team to ensure maintenance of Key entities ‘license supporting the BD pharmaceutical Quality System
Liaise with the global Infection Prevention team, including local offices, marketing/sales organization or local distributors, US manufacturing and R&D, to ensure that the existing pharmaceutical Quality requirements are known and controlled.
Liaise and manage processes with EU quality team for logistics flows to ensure compliance with applicable pharmaceutical regulations.
When/ if applicable liaise with global trade team to ensure compliance of importation process
Provide timely support when requested by these organizations in supporting the preparation of necessary quality documents
Proactively follow-up on Quality issues to monitor product issues in the field and ensure that they are addressed in a timely manner.
Escalate any significant Quality issues and provide leadership and direction regarding quality decisions.
Provide Quality assessments on change controls / design control documentation (as needed) to ensure regulatory compliance with Quality requirements in International Markets.
Report to the Management on the performances of the Pharmaceutical Quality Management System, including any needs for improvement.
Compile batch release file to ensure the GMP release of the product for the regional European market. Liaise with the different QPs involved in Regional supply chain to ensure clarification of potential questions and release in a timely manner
When/if applicable, ensure that sub-contracted pharmaceutical distributors and key entities with GMP/ GDP activities are regularly audited and are performing in accordance with corporate requirements.
When requested by ChloraPrep manufacturing divisions, launch, document and monitor product recalls and any other remedial field actions in the affected territories and closely follow-up on the timely closure of these actions.
Excellent written and oral English required (Dutch a plus)
5 years’ experience in European Quality in an International (outside US) organization
Healthcare/Pharmaceutical – regulated environment or equivalent experience
Must have strong knowledge of global pharmaceutical regulations and industry notably in GMP.
Ability to read professional journals, technical procedures or governmental regulations. Ability to write reports, registration modules and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Reasoning ability: Able to define problems, collect data, establish facts, and draw valid conclusions. Able to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Other skills and abilities: Excellent verbal and written communication skills, strong negotiation and facilitation skills, and strong project coordination and management skills. Structured and largely self-organized.
Work environment: The employee must be able to travel 25% of time. The demands of travel may expose the employee to higher noise levels and common hazards associated with travelling. Work is performed in a normal office environment with little exposure to excessive noise, dust, temperature, etc. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
It’s a superb, all-round QA Pharma Specialist career development role with a world leader in medical devices. So i f this describes you and your aspirations, then please click on the APPLY button.
Primary Work Location
BEL Erembodegem - Dorp 86
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.