Senior Associate, Quality Assurance

vor 3 Wochen

Munich, Deutschland Biogen Vollzeit

Job Description

For our office in Munich (in a hybrid working model) we are recruiting for a 

Senior Associate, Quality Assurance (f/m/d) 

The Senior Associate, Quality Assurance (f/m/d) for the German Affiliate is dedicated to providing comprehensive support to the Responsible Person in accordance with §52a AMG, §2(1) of the German GDP regulation (AM-HandelsV), and EU-GDP guidelines, ensuring strict compliance with GDP license requirements. The responsibilities include recognizing, documenting, and executing deviations, Corrective and Preventive Actions (CAPAs), and change controls as well as reporting adverse events and technical product complaints to the relevant department or service provider responsible for processing reports, in accordance with local Standard Operating Procedures (SOPs).

This role serves as a vital link in maintaining adherence to regulatory standards and ensuring the integrity of pharmaceutical operations within the German Affiliate.

What you'll do

Support the Responsible Person on the maintenance of the Local Quality Management System consisten with in-country requirements and Biogen QMS: Back-up for Quality Management Review coordinatorLocal implementation and alignment of Global Quality Management Systems (Global Directives).Training plan review and support of training assignmentsPerforming the revision for local Quality controlled documents within the documentation management system for local procedures
  Support the Responsible Person on the maintenance of German Wholesaler Distribution Authorization, and Marketing Authorization  Ensures that suppliers are qualifiedEnsures that customers are qualified in coordination with responsible departments and third party service providersManage return requests and perform a first assessmentIs up-to-date with cGDP and German regulatory requirements
Supports GMP/GDP-related Audits and Inspections: Supports GDP inspections with preparation readiness and required follow-up and CAPA implementation in close collaboration with the RP.Supports Affiliate Audits and coordinates related follow up and CAPA implementation in close collaboration with the RPEnsures that corrective and preventive actions are introduced as outcome of self-inspections performed at the German affiliate Product and Distribution related issues as Deputy Responsible Person - Germany: Support Product Recall and local mock recall exercises.Supports Technical Product Complaint related investigations, follow-up as necessary and replacement requests.Ensures that suspected falsified product is immediately notified for investigation and supports coordination of local management.Supports the Responsible Person to ensure that all communication to the authorities is appropriate, coordinated and approved.Supports temperature excursion assessments within Germany

Who you are

You possess a meticulous attention to detail coupled with a proactive approach to problem-solving, effective communication skills and the ability to collaborate seamlessly with cross-functional teams. You foster a culture of continuous improvement and excellence in quality assurance practices.

Qualifications

Preferably Master Degree in Pharmacy, or equivalent, as per Section 15 AMG Min. 2 years ofexperience within quality/or related functions in pharma/biotech/life sciences  Knowledge of Directive 2011/62/EC (FMD) in conjunction with Commission Delegated Regulation (EU) 2016/161, AMG 2024 and Good Distribution Practice preferred Ability to set priorities and work independently Organized and structured working method Ability to work within predefined processes Fluency in German and English 

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts

  • Associate Director, Quality Assurance

    vor 4 Wochen

    Munich, Deutschland Proclinical Vollzeit

    Proclinical are recruiting an Associate Director, Quality Assurance (RP) for a biotech organisation. This role is on a permanent basis and is located in Munich. The client is focused on creating, manufacturing and commercialising transformative remedies for those who suffer from serious illnesses. **Responsibilities**: - Supervise GMP/GXP compliance to...

  • Senior Quality Assurance Auditor

    vor 3 Wochen

    Munich, Deutschland SciPro Vollzeit

    Client & Role summary: My client is part of a global group and in this unit, they are producing OTC and other healthcare products. In this position, you will be responsible for Audit & Supplier Management and act like SME in this Quality unit. YOUR TASKSAs a senior QA, your main responsibility within our QM system is to ensure the qualification of external...

  • Senior Quality Assurance Engineer

    vor 3 Wochen

    Munich, Deutschland Yoummday Vollzeit

    Deine AufgabenWir verändern eine ganze Branche – verändere sie gemeinsam mit uns! You made my day – mit unserer innovativen und marktumwälzenden Plattform geben wir bereits einer Vielzahl von Menschen weltweit Zugang zu einer neuen, flexiblen und selbstbestimmten Arbeitswelt und bieten unseren Kunden durch unsere Software gleichzeitig einen komplett...

  • Senior Quality Assurance Engineer

    vor 4 Wochen

    Munich, Deutschland Yoummday Vollzeit

    Deine Aufgaben Wir verändern eine ganze Branche – verändere sie gemeinsam mit uns! You made my day – mit unserer innovativen und marktumwälzenden Plattform geben wir bereits einer Vielzahl von Menschen weltweit Zugang zu einer neuen, flexiblen und selbstbestimmten Arbeitswelt und bieten unseren Kunden durch unsere Software gleichzeitig einen...

  • Senior Quality Assurance Engineer

    vor 3 Wochen

    Munich, Deutschland Yoummday Vollzeit

    Deine Aufgaben Wir verändern eine ganze Branche – verändere sie gemeinsam mit uns! You made my day – mit unserer innovativen und marktumwälzenden Plattform geben wir bereits einer Vielzahl von Menschen weltweit Zugang zu einer neuen, flexiblen und selbstbestimmten Arbeitswelt und bieten unseren Kunden durch unsere Software gleichzeitig einen...

  • Quality Assurance Assistant

    vor 4 Wochen

    Munich, Deutschland vivoPharm Vollzeit

    RDDT, a vivoPharm Company Gilles Plains SA 5086 Science & Technology Quality Assurance & Control vivoPharm, a Vyantbio Company, is a contract research organization supporting the preclinical research needs of the biotechnology/pharmaceutical sectors. It offers an extensive portfolio of contract services for preclinical drug development and clinical support...

  • QA Quality Assurance Lead Munich Germany

    Vor 5 Tagen

    Munich, Deutschland Nexus Recruitment Vollzeit

    Job Reference: NJ0101 - Date Posted: 16 April 2023 - Recruiter: Nexus Jobs - Location: Munich Germany - Salary: €300 to €600 Per Day - Sector: I.T. & Communications - Job Type: Contract - Duration: 6 months - Work Hours: Full Time - Contact: Jas Gujral - Telephone: 020 7488 6900 QA Quality Assurance Lead Munich Germany The Quality Assurance Lead must...

  • QA Quality Assurance Lead Munich Germany

    vor 2 Wochen

    Munich, Bayern, Deutschland Nexus Jobs Limited Vollzeit

    Job Description QA Quality Assurance Lead Munich Germany The Quality Assurance Lead must have at least 5 to 10 years experience in systems testing. Must have the ability to impose assertiveness and leadership qualities with clear a demonstration of leading the quality assurance processes and transformation. You will be driving teams towards change and...

  • Quality Assurance Manager with German

    Vor 4 Tagen

    Munich, Deutschland Traffective GmbH Vollzeit

    ️‍♀️ Quality Assurance Manager with German wanted! ️‍♂️As a QA Manager, you'll be responsible for developing and implementing quality management strategies according to the latest ITIL standards. You play a crucial role in ensuring that the performance, quality, and effectiveness of our IT services continually improve.About us

  • Quality Assurance Tester

    vor 4 Wochen

    Munich, Deutschland Eve Systems GmbH Vollzeit

    Zur Ergänzung unseres Quality Assurance-Teams in München suchen wir einen Quality Assurance Tester (m/w/d). Dein Aufgabengebiet: - Durchführung von Tests gemäß den Testplänen auf verschiedenen Betriebssystemen - Dokumentation und Analyse der Testergebnisse - Konzeption von Testplänen für neue Produkte - Unterstützung des Engineering-Teams bei...

  • Working Student Supplier Quality Assurance

    vor 4 Wochen

    Munich, Deutschland Beckman Coulter Diagnostics Vollzeit

    **Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.** At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...

  • Quality Assurance Manager

    vor 3 Wochen

    Munich, Deutschland WuXi AppTec Vollzeit

    OverviewThis position is responsible for organizing, planning and managing the personnel, systems and resources critical to the daily operation of the department(s). The Manager works cross functionally to ensure processes and procedures in place to align with regulatory requirements.ResponsibilitiesLead and manage employees to ensure that employees are...

  • Quality Assurance Test Specialist

    Vor 4 Tagen

    Munich, Deutschland NOVENTI Health SE Vollzeit

    NOVENTI ist der führende Anbieter von Software, Finanzdienstleistungen und digitalen Plattformen im europäischen Gesundheitsmarkt. Das Angebot richtet sich an alle Leistungserbringer des Gesundheitswesens, wie z.B. Apotheken, Physiotherapie, Sanitätshäuser, Pflegedienste und Arztpraxen. Wir begleiten unsere Kundinnen und Kunden in digitalen...

  • Senior Manufacturing Quality Technician

    vor 4 Wochen

    Munich, Deutschland Beckman Coulter Diagnostics Vollzeit

    **Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.** At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...

  • Quality Assurance Specialist

    Vor 4 Tagen

    Munich, Deutschland Rolls-Royce Vollzeit

    **Job Description**: **Quality Assurance Specialist (f/m/d)** **Full time** **Munich, Dahlewitz or Cottbus / Hybrid** **Why Rolls-Royce?** An exciting opportunity has arisen for a **Quality Assurance Specialist for Manufacturing and Testing (f/m/d) **to join Rolls-Royce Electrical in **Dahlewitz near Berlin, Cottbus or Munich. **In this role you will...

  • Quality Assurance Specialist

    Vor 4 Tagen

    Munich, Deutschland experts Vollzeit

    Quality Assurance Specialist (m/w/d) **Experten. Talente. Persönlichkeiten.**: Vorreiter in Tierarzneimitteln werden: Gestalten Sie die Zukunft mit! Für unseren Partner in der innovativen Tiermedizin suchen wir einen **Quality Assurance Specialist (m/w/d) für den München.** - Wenn Sie Ihre Leidenschaft für regulatorische Angelegenheiten in der...

  • Quality Assurance Engineer

    vor 2 Wochen

    Munich, Deutschland Real Staffing Vollzeit

    Wir suchen für ein international etablierten und stark wachsenden Spezialisten aus Mittelfranken für Produktion und Entwicklung von bildgebenden Medizinprodukten ab sofort einen Quality Assurance Engineer (m/w/d) in unbefristeter Festanstellung.Sollten Sie offen für eine neue Position im Bereich Qualitätswesen / Qualitätsmanagement / Qualitätssicherung...

  • Programme Quality Assurance Suz

    vor 4 Wochen

    Munich, Deutschland Argo Aviation GmbH Vollzeit

    **Imagetext / Arbeitgebervorstellung** Wie soll Ihr nächster Job aussehen? Die Luftfahrtindustrie sucht eine Reihe von Qualifikationen und benötigt Ihr persönliches und fachliches Knowhow. Fühlen Sie sich angesprochen? Argo Aviation bringt Sie direkt zum Take-off - schnell und präzise. Für unseren Kunden **AIRBUS **suchen wir zum nächstmöglichen...

  • Senior Associate

    vor 3 Wochen

    Munich, Bayern, Deutschland Alvarez and Marsal Vollzeit

    Description Companies, investors, and government entities worldwide rely on Alvarez & Marsal (A&M) for exceptional leadership and tangible results. Established in 1983, A&M is a global professional services firm that specializes in advisory, business performance improvement, and turnaround management services.With over 9,000 professionals spanning 6...

  • Senior Manufacturing Quality Technician

    vor 4 Wochen

    Munich, Deutschland Danaher Vollzeit

    Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...