BD (Becton, Dickinson and Company) Pharma QA specialist / Swiss QP backup in Eysins, Switzerland
Job Description Summary
Act as quality specialist to create and maintain Pharma quality systems (GMP and GDP compliant) for the key pharma entities regionally involved to support the business associated to pharma product included in the BD portfolio. Act as a Swiss qualified person backup and assist the Swiss qualified person in all of his/ her responsibilities.
As Pharma QA Specialist / Swiss QP Backup reporting to our QA Manager Infection prevention, OUS , you will act as quality specialist to create and maintain Pharma quality systems (GMP and GDP compliant) for the key pharma entities regionally involved to support the business associated to pharma product included in the BD portfolio. Act as a Swiss qualified person backup and assist the Swiss qualified person in all of his/ her responsibilities.
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 sales and distribution Quality system.
Liaise with Regulatory team to ensure maintenance of Key entities ‘license supporting the BD pharmaceutical Quality System
Act as Swiss acting Qualified Person according to Swissmedic’s medicinal products regulation each time required and in absence of the Swiss qualified person. Assist the Swiss QP in all the tasks and responsibilities linked to his/her role.
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.
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.
Report to the Management on the performances of the Pharmaceutical Quality Management System, including any needs for improvement.
Manage batch release for sale for the European market and GMP release for Swiss market in absence of the Swiss Qualified Person
Ensure GMP compliance of product intended for the Swiss market, including deviations and reworks when/if applicable.
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.
Pharmacist or eligible to be QP, you’ll need at least 3 years’ experience in a Quality and Regulatory Affairs position within a regulated environment and international organization. A good knowledge of GMP/GDP is mandatory and any experience in batch release, inspections and audits a plus. A conversational level of English is required as well.
Proactive, with excellent verbal and written communication skills , you’ll also bring:
Strong negotiation and facilitation skills, and strong project coordination and management skills.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Able to define problems, collect data, establish facts, and draw valid conclusions
Ability to travel 25% of time
It’s a superb, all-round QA 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
CHE Eysins - Business Park Terre-Bonne
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.