Quality Assurance Leader
vor 3 Wochen
**Job Description Summary**: In this global key Quality role you will develop and maintain Quality systems, rules, and processes to ensure the fulfillment of internal and external quality requirements related to distribution and logistics processes for our time critical pharmaceutical products. You will proactively ensure that projects and products are capable and will meet specified standards. With your in-depth understanding of key business drivers you will use this understanding to accomplish your missions. With a strong leadership ability you understand the interdependencies between the different teams globally to achieve the common objectives in Quality.
At GE Healthcare we’re creating what doctors, researchers, and scientists need to pursue a healthy future. For us, healthcare is more than just a business—it’s a mission. It’s what drives us to make every moment matter for ourselves, our customers, and their patients.
In close cooperation with our Manufacturing and global distribution site in Braunschweig Germany for Radiopharmaceutical Products you will hold the QA responsibility as designated Responsible Person (RP) for the wholesale distribution activities of GE Healthcare Buchler, under a Wholesale Dealer’s Authorisation, and will support of GDP activities for GE Healthcare Buchler Manufactured products.
This role can be based anywhere in Germany
Key Responsibilities include:
Quality Management System - Good Distribution Practices (GDP)
- You will be working with the Manufacturing site QMS, to develop, implement and maintain procedures relating to the wholesale distribution activities of distributed products and supporting activities related to distribution of manufactured products
- You hold the RP responsibilities for warehouse storage and outbound deliveries of products to end customers in Germany
- You manage outsourced activities - 3PL, local carriers, including supplier qualification, audits and Quality and Technical Agreements
- You are responsible for the Quality Risk Management of the wholesale distribution operation and oversee the customer qualification process
- You assist in developing and delivering training for functions supporting GDP activities
- You liaise with regulatory authorities regarding activities related to the wholesale distribution activities of distributed products under the WDA
- You hold the RP responsibilities for returns (final disposition of returned, rejected, recalled or falsified products), product recalls where required and are the Point of Contact for Customer Complaints related to distribution
- You will perform Self-inspection and Internal Audit and host Quality System Audits (internal and external)
- You are responsible for Deviations, Investigations, Corrective Actions relating to the wholesale distribution operation and QA support for other GDP activities
- You will constantly monitor and review our Quality System for effectiveness and implementation of continuous improvement programs
Your Profile:
- You hold a University degree in pharmacy, human sciences, dentistry or veterinary medicine, chemistry, biology or food and biotechnology.
- You are eligible to be designated a Responsible Person on a Wholesale Dealer’s Authorisation in Germany and were ideally prior designated as a Responsible Person on a Wholesale Dealer’s Authorisation
- You bring a proven relevant professional experience as a Responsible Person in the pharmaceutical industry, preferably in a Distribution or Manufacturing environment.
- You bring fluent Language skills in English and German in written and spoken
- You bring the experience in dealing with competent authorities
- You bring strong problem solving skills and an experience in auditing (as auditor and auditee)
- Your high degree of self-motivation and self-responsibility together with strong influencing abilities help you to work with cross functional and a multinational team
**About GE Healthcare**
**Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
**Inclusion and Diversity**
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE Healthcare - every moment matters
LI-KRONE
LI-REMOTE
**Additional Information**:
**Relocation Assistance Provided**:No
-
Radiochemist and Operations Specialist
vor 7 Monaten
Braunschweig, Deutschland Scitech Engineering Ltd VollzeitJob Advert Scitech is a leading Pharmaceutical consultancy at the forefront of radiopharmaceutical innovation. With over 20 years of continuous experience, we specialise in providing comprehensive consulting services to clients in the radiopharma industry, offering expertise in regulatory compliance, quality assurance, and facility design. Our newly...
-
Regional-Leiter Quality Center Operations
vor 2 Monaten
Braunschweig, Deutschland CSL Plasma GmbH Vollzeitp> CSL Plasma, als ein Unternehmen der CSL Behring Gruppe, ist eines der weltweit größten Unternehmen zur Gewinnung von Humanplasma für die Herstellung von hochwirksamen Gerinnungs- und Immunglobulinpräparaten. Neben dem reibungslosen Ablauf sind nicht nur Qualität, Sicherheit und modernste Technik wichtig, sondern vor allem unsere qualifizierten und...
-
Regional-Leiter Quality Center Operations
vor 2 Monaten
Braunschweig, Deutschland CSL Plasma GmbH VollzeitCSL Plasma, als ein Unternehmen der CSL Behring Gruppe, ist eines der weltweit größten Unternehmen zur Gewinnung von Humanplasma für die Herstellung von hochwirksamen Gerinnungs- und Immunglobulinpräparaten. Neben dem reibungslosen Ablauf sind nicht nur Qualität, Sicherheit und modernste Technik wichtig, sondern vor allem unsere qualifizierten und...
-
Regional Manager Quality Operations
vor 4 Wochen
Braunschweig, Deutschland CSL Behring VollzeitCSL Plasma, als ein Unternehmen der CSL Behring Gruppe, ist eines der weltweit größten Unternehmen zur Gewinnung von Humanplasma für die Herstellung von hochwirksamen Gerinnungs- und Immunglobulinpräparaten. Neben dem reibungslosen Ablauf sind nicht nur Qualität, Sicherheit und modernste Technik wichtig, sondern vor allem unsere qualifizierten und...
-
Regional-Leiter Quality Center Operations
vor 2 Monaten
Braunschweig, Deutschland CSL Plasma GmbH VollzeitCSL Plasma, als ein Unternehmen der CSL Behring Gruppe, ist eines der weltweit größten Unternehmen zur Gewinnung von Humanplasma für die Herstellung von hochwirksamen Gerinnungs- und Immunglobulinpräparaten. Neben dem reibungslosen Ablauf sind nicht nur Qualität, Sicherheit und modernste Technik wichtig, sondern vor allem unsere qualifizierten und...
-
Housekeeper
vor 7 Monaten
Braunschweig, Deutschland Optima Hotelservice UG Vollzeit-Englisch is below- - Über uns: Die OPTIMA ist ein Dienstleistungsunternehmen, welches sich auf Serviceleistungen für die Hotellerie spezialisiert hat. Neben verschiedenen Housekeeping Dienstleistungen werden auch Facility Management, Reparaturen und weiteres angeboten. Deine Aufgaben bei uns: Unsere MitarbeiterInnen des Housekeepings setzen täglich...
-
Lead Space System Simulator Developer
vor 4 Wochen
Braunschweig, Niedersachsen, Deutschland etamax Space VollzeitJob OverviewWe are seeking a highly experienced Lead Space System Simulator Developer to lead our simulator development team at etamax Space. The successful candidate will design, develop, and implement simulation models of satellite equipment and space environment.About the RoleLead the development of simulation models of satellite equipment and space...
-
Onb Test
vor 7 Monaten
Braunschweig, Deutschland ALSTOM VollzeitAt Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, more than 80 000 colleagues lead the way to greener and smarter mobility...
-
Finishing Lead
vor 3 Wochen
Braunschweig, Deutschland Johns Manville VollzeitJohns Manville is committed to delivering positive and powerful experiences, because we are successful only when our employees and customers thrive. We are passionate, we care about people, we perform at a superior level, and we protect others and our environments. Essential **Responsibilities**: This is a production position supervising the workflow of the...
-
Mpa Lead
vor 3 Wochen
Braunschweig, Deutschland Johns Manville VollzeitJohns Manville is committed to delivering positive and powerful experiences, because we are successful only when our employees and customers thrive. We are passionate, we care about people, we perform at a superior level, and we protect others and our environments. The base hourly rate for this position is $22.23 Essential **Responsibilities**: This is a...
-
Mpa Lead
vor 7 Monaten
Braunschweig, Deutschland Johns Manville VollzeitWho We Are - A proud member of the Berkshire Hathaway family of companies, we serve customers in more than 80 countries around the globe. We are committed to delivering positive and powerful experiences, because we are successful only when our employees and customers thrive. We are passionate, we care about people, we perform at a superior level, and we...
-
Scientific Lead Silva Database
vor 7 Monaten
Braunschweig, Deutschland Leibniz Institut DSMZ - Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH Vollzeit**Job offer 12/24** The Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures GmbH, Braunschweig offers the position for a **Scientific Lead SILVA Database (M/F/d)** The position has a salary level up to TV-L 14 according to the qualification and is initially limited to 2 years with the perspective to become a **permanent...
-
Qualitätsmanagementbeauftragten
vor 4 Monaten
Braunschweig, Deutschland CSL Behring Vollzeit**Job Description**: Für unsere Abteilung **Quality Assurance **suchen wir in unserem Plasmacenter in **Braunschweig **einen Qualitätsmanagementbeauftragten (m/w/x) (Vollzeit / befristet für 2 Jahre) **Sie sind für folgende Aufgaben verantwortlich**: - Betreuung, Implementierung und Überprüfung von Maßnahmen zur Qualitätssicherung unter Anwendung...
-
Leitung Technik, m/w/d
vor 2 Monaten
Braunschweig, Deutschland CSL Plasma GmbH VollzeitCSL Plasma, als ein Unternehmen der CSL Behring Gruppe, ist eines der weltweit größten Unternehmen zur Gewinnung von Humanplasma für die Herstellung von hochwirksamen Gerinnungs- und Immunglobulinpräparaten. Neben dem reibungslosen Ablauf sind nicht nur Qualität, Sicherheit und modernste Technik wichtig, sondern vor allem unsere qualifizierten und...
-
Fullstack Developer
vor 2 Monaten
Braunschweig, Deutschland smartmicro VollzeitWe are smartmicro, leading specialist in high-performance automotive and traffic radar sensor technology. We design, develop and manufacture high-tech radar sensors for autonomous driving, intelligent traffic infrastructure and smart cities. Our mission is to make roads safer, enable autonomous driving in all-weather scenarios, optimize traffic flow for...
-
E-commerce Lead
vor 4 Monaten
Braunschweig, Deutschland ARCTIC GmbH Vollzeit**About ARCTIC** ARCTIC is a leading manufacturer of silent PC cooling systems and components, having pioneered and shaped the trend towards quiet cooling solutions. Offering a wide range of CPU air and water coolers, monitor arms, wall mounts, and thermal materials, ARCTIC has won the trust of PC enthusiasts in over 56 countries. Under the leadership of...
-
E-commerce Lead
vor 3 Monaten
Braunschweig, Deutschland ARCTIC GmbH Vollzeit**About ARCTIC** ARCTIC is a leading manufacturer of silent PC cooling systems and components, having pioneered and shaped the trend towards quiet cooling solutions. Offering a wide range of CPU air and water coolers, monitor arms, wall mounts, and thermal materials, ARCTIC has won the trust of PC enthusiasts in over 56 countries. Under the leadership of...
-
Production Assistant
vor 2 Wochen
Braunschweig, Deutschland 908 Devices Vollzeit**908 Devices Inc. **has developed an innovative suite of purpose-built handheld and desktop mass spec devices for the point-of-need. Leveraging our proprietary platform technology, we make the extraordinary analytical power of mass spec available in significantly smaller and more accessible devices than conventional laboratory instruments. Our devices are...
-
Kitchen Employee
vor 2 Monaten
Braunschweig, Deutschland Burgermeister VollzeitBurgermeister is a dynamic food service company specializing in high-quality burgers and customer-oriented service. With our passion for innovation and quality, we strive to be a leader in all aspects of our business. Aufgaben For our Braunschweig restaurant, we are looking for dedicated employees for the kitchen / grill / cash register. You prepare our...
-
E-commerce Lead
vor 3 Monaten
Braunschweig, Deutschland ARCTIC GmbH Vollzeit**What makes working at ARCTIC special is our positive, international working environment. We enjoy what we do!**: Respectful cooperation is important to us. We maintain an open dialog and consider the motivation of our employees as decisive for our success. We encourage the personal and professional development of our employees. Together we work out...
