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Quality specialist Jobs in Köln

Zuletzt aktualisiert: vor 22 Stunden
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Clinical Trials Quality Compliance Specialist mwd

Clinical Trials Quality Compliance Specialist mwd

Miltenyi BiotecBergisch Gladbach, Germany
You are working in the Clinical Research & Development department which conducts firstinman clinical trials and Phase III proofofconcept studies for our new assets worldwide.You ensure GCP comp...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Quality Assurance Engineer

Quality Assurance Engineer

Taxy GmbHKöln, Deutschland
Du übernimmst eine anspruchsvolle Rolle bei Taxy.Verantwortung für die Konzeption, Weiterentwicklungund Optimierung unserer Tests tragen wirst. IhreHauptaufgaben : Entwickelst zukunftssichere Teststra...Mehr anzeigenZuletzt aktualisiert: vor 2 Tagen
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Professur für Code Quality

Professur für Code Quality

Technische Hochschule KölnKöln, Deutschland
Der Campus zeichnet sich durch eine sehr gute technische Infrastruktur und innovative Lernräume aus.Mit 30 Professor •innen in der Lehreinheit Informatik gehört der Standort zu einem der stärksten a...Mehr anzeigenZuletzt aktualisiert: vor 28 Tagen
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Teamleiter (m / w / d) Quality Assurance

Teamleiter (m / w / d) Quality Assurance

Autoflug GmbHCologne, DE
Über unsTHINKING SAFETY – diesem Motto verpflichtet ist AUTOFLUG bereits seit den Anfangstagen der Luftfahrt ein führender Anbieter von Produkten und Leistungen, bei denen die Rettung und Sicherhei...Mehr anzeigenZuletzt aktualisiert: vor 2 Tagen
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Supplier Quality Engineer (m / w / d) – Teilzeit

Supplier Quality Engineer (m / w / d) – Teilzeit

Heraeus Epurio GmbHLeverkusen, Deutschland
Displays faltbar machen? Herzen mit Mikro-Teilchen beim Schlagen helfen? Oder Edelmetallen neues Leben ein­hauchen? Als globale Technologie­gruppe in Familien­besitz unter­stützen wir unsere Kunden...Mehr anzeigenZuletzt aktualisiert: vor 3 Tagen
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Sales Specialist

Sales Specialist

JD Ross EnergyCologne, North Rhine-Westphalia, Germany
SALES SPECIALIST - HEAT PUMPS - COLOGNE.JD Ross is collaborating with an international wholesaler in their search for a Heat Pump Specialist for Germany. The company is operating throughout the whol...Mehr anzeigenZuletzt aktualisiert: vor 3 Tagen
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Accounting Specialist

Accounting Specialist

Ciklo TalentCologne , DE
Referent Bilanzierung / Accounting Expert (m / w / d).Remote in Deutschland (flexible Arbeitsmodelle).Referenten Bilanzierung / Accounting Expert (m / w / d). Unser Partner setzt auf innovative Lösungen und...Mehr anzeigenZuletzt aktualisiert: vor 2 Tagen
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Quality Auditor

Quality Auditor

Life Science PeopleCologne , DE
A leading Notified Body in Germany are rapidly expanding their Audit teams as a result of large project acquisitions.This Notified Body has numerous subsidiaries across Europe and offers world reno...Mehr anzeigenZuletzt aktualisiert: vor 17 Tagen
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Immigration Specialist

Immigration Specialist

Pattison Shepley RuvoloCologne , DE
International organisation has a brand-new requirement for an Immigration Specialist to advise on German immigration legislation. You will provide main point of contact service to a range of high pr...Mehr anzeigenZuletzt aktualisiert: vor 17 Tagen
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Security Specialist

Security Specialist

AltiaCologne, North Rhine-Westphalia, Germany
Are you ready for a new professional challenge? Check out our exciting opportunity!.We are an IT Consulting Group that delivers innovative digital solutions to improve citizens' lives across Europe...Mehr anzeigenZuletzt aktualisiert: vor 19 Tagen
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Quality Supplier Auditor (m / w / d)

Quality Supplier Auditor (m / w / d)

SciProCologne Germany
Quality Supplier Auditor (m / w / d) im Bereich Medizintechnik oder Pharma.Ein führendes Unternehmen im Bereich der Auftragsentwicklung- und Herstellung. Neben der GMP-Herstellung bietet das Unternehmen...Mehr anzeigenZuletzt aktualisiert: vor 7 Tagen
Quality Manager (m / f / d)

Quality Manager (m / f / d)

GULP – experts unitedCologne
If you are thinking about a new career start, then we should talk! Our subsidiary Randstad professional solutions currently has an exciting vacancy for a. A variety of tasks, a working atmosphere ch...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Assurance Specialist (d / f / m)

Quality Assurance Specialist (d / f / m)

cleverbridgeCologne
Vollzeit
Cologne For our team in Cologne, we are currently looking for a Quality Assurance Specialist (m / f / d).You want to enrich us with your passion for quality? You want to support the development and mai...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Quality Manager

Quality Manager

Discover InternationalCologne Germany
Hybrid in North Rhine-Westphalia.Optimize customer QA processes, including handling queries, questionnaires, agreements, and complaints, with a focus on digitalization. Initiate and implement struct...Mehr anzeigenZuletzt aktualisiert: vor 12 Tagen
Specialist Quality and Environmental Management (m / w / d)

Specialist Quality and Environmental Management (m / w / d)

HimaBrühl
Unsere Mitarbeiterinnen und Mitarbeiter arbeiten auf allen Kontinenten mit viel Leidenschaft an einem gemeinsamen Ziel : Dem nachhaltigen Schutz von Mensch und Umwelt. Mit unserem Portfolio, das von ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Chief Quality Officer

Chief Quality Officer

Mantell AssociatesCologne , DE
Mantell Associates is currently partnered with a biopharma CDMO with a focus on advanced therapeutics and critical medicines. They are seeking a Chief Quality Officer to join their growing leadershi...Mehr anzeigenZuletzt aktualisiert: vor 22 Stunden
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Professional Quality Assurance (m / w / d) gesucht!

Professional Quality Assurance (m / w / d) gesucht!

Metallverarbeitungsindustrie (für Luftfahrt, Elektronik etc.)Cologne, DE
Über unsÜber uns Unser Kunde entwickelt und fertigt Fräs-, Dreh und Blechteile aus Metall und Kunststoff für anspruchsvolle Kundschaft aus den Branchen Luftfahrt und Nautik, Optik und Elektronik, s...Mehr anzeigenZuletzt aktualisiert: vor 6 Tagen
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CPP specialist

CPP specialist

VBeyond EuropeCologne , DE
The job description is for an Ancillary Associate, whose main responsibilities include arranging and compiling legal documents, such as CPP, Mfg Lic, GMP, FSC and others, from various sources, such...Mehr anzeigenZuletzt aktualisiert: vor 7 Tagen
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Clinical Trials Quality Compliance Specialist mwd

Clinical Trials Quality Compliance Specialist mwd

Miltenyi BiotecBergisch Gladbach, Germany
Vor 30+ Tagen
Stellenbeschreibung

Your role

You are working in the Clinical Research & Development department which conducts firstinman clinical trials and Phase III proofofconcept studies for our new assets worldwide.

  • You ensure GCP compliance for the clinical trials in collaboration with Quality Assurance to support our departments objectives in meeting and GCPcompliance by providing structure identifying and supporting the resolution of issues on trial and process level through
  • With respect to our activities you closely collaborate with the Quality Assurance department and crossfunctional Clinical Research & Development teams to develop QA / QC measures
  • In addition you also plan and conduct activities related to compliance and inspection readiness including quality checks of TMFs and processes. You review and improve processes for efficiency effectiveness and compliance with regulations guidelines and quality policies and support site / CRO assessments.
  • You will also coordinate and support functional / clinical trial teams in audit / inspection activities to ensure a consistent approach / action across clinical trials and programs. To improve functional processes and foster a culture of continuous improvement you identify analyze track and resolve findings regulatory and process gaps / nonconformances.
  • By developing and implementing a lessonslearned culture you help to improve the quality of processes and documentation (in compliance with regulations guidelines quality policies) and minimize associated trial risks.

Qualifications :

  • You hold a Bachelors Degree or equivalent qualification in Life Sciences / Healthcare; Masters degree preferred.
  • You have several years of clinical / industry / health authority experience including a strong focus on quality and compliance. You acquired a thorough knowledge of Good Clinical Practice regulatory guidelines (FDA / EMA / ICH) and the clinical development process. In addition you are experienced in audits or inspections (e.g. FDA EMA).
  • You have strong analytical skills with attention to detail and are a problem solver. You are a highly motivated openminded team player with a proven ability to take initiative prioritize and meet project deadlines in a dynamic environment.
  • You are naturally communicative and have effective communication (verbal and written) and organizational skills both in English and German.
  • A sound knowledge of Microsoft and electronic clinical trial applications e.g. eCRF eTMF or CTMS is expected.

    • Remote Work : Employment Type :

    Fulltime