Senior Specialist Quality Assurance Systems Specialist

Vor 6 Tagen

Krems an der Donau, Niederösterreich, Österreich Merck Sharp & Dohme Vollzeit
Job Description

Our Quality Assurance team is responsible for ensuring that all materials used in our products meet the highest standards of quality and regulatory requirements. We partner with internal manufacturing facilities, external contract manufacturers, and suppliers to create a global manufacturing network that delivers compliant, reliable supplies to customers and patients worldwide.

Key Responsibilities:

  • Provide quality support in preparation for USDA certification and product transfer projects according to Austrian Drug Law (AMG), European GMP, EU 2019/6, and USDA.
  • Perform compliance gap assessments versus USDA requirements and coordinate remediation action implementation to ensure timely completion.
  • Develop and implement quality remediation actions, including creation, review, and approval of relevant SOPs, qualification and validation protocols and reports, manufacturing instructions, and GMP documents.
  • Participate in official inspections and self-inspections to ensure compliance with regulatory requirements.
  • Contribute to the implementation of quality and compliance excellence for continuous improvement and efficiency throughout the quality and compliance functions.

Requirements:

  • Bachelor's degree in (Bio)chemistry, Biology, or a scientific field.
  • Minimum 7-8 years of experience in a Pharmaceutical GMP environment.
  • Knowledge of USDA requirements for US animal health vaccines is an advantage.
  • Good knowledge of EU GMP regulations and (V)ICH guidelines.
  • Knowledge of PDA and ISPE guidelines.
  • Good project management skills.
  • Fluent in German and English.

What We Offer:

  • A unique opportunity to participate in the establishment of a state-of-the-art production site.
  • Diversified responsibilities in an international environment.
  • Collaboration with professional and highly motivated team members.
  • Participation in a respectful and positive working climate.
  • Attractive career opportunities and good training and development possibilities.
  • Attractive company benefits.

  • Senior Specialist Quality Assurance Systems Specialist

    Vor 2 Tagen

    Krems an der Donau, Niederösterreich, Österreich Merck Sharp & Dohme Vollzeit

    About the RoleWe are seeking a highly skilled Senior Specialist Quality Assurance Systems to join our team at Merck Sharp & Dohme. As a key member of our Quality Assurance group, you will play a critical role in ensuring the highest standards of quality and compliance in our manufacturing processes.Key ResponsibilitiesProvide quality support in preparation...

  • Senior Specialist Quality Assurance Systems

    vor 1 Monat

    Krems an der Donau, Niederösterreich, Österreich Merck Sharp & Dohme Corp. Vollzeit

    Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we...

  • Associate Specialist Quality Support

    vor 4 Wochen

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job DescriptionDas erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur...

  • IT Support Specialist

    Vor 4 Tagen

    Krems an der Donau, Niederösterreich, Österreich A&O IT Group Vollzeit

    About the JobWe are seeking a highly skilled IT Support Specialist to join our team at A&O IT Group.As a key member of our global team, you will be responsible for providing top-notch technical support to our clients, ensuring their IT systems are running smoothly and efficiently.Key Responsibilities:Handle Incidents and Service Requests and provide near...

  • IT Support Specialist

    Vor 6 Tagen

    Krems an der Donau, Niederösterreich, Österreich A&O IT Group Vollzeit

    About the JobA&O IT Group is seeking a skilled IT Support Specialist to join our global team of over 1,000 engineer support heroes.As a key member of our team, you will work with some of the world's leading brands, from high-street giants to energy multinationals and financial institutions.You will have the opportunity to gain exposure to the latest hardware...

  • Qualitätsmanagement-Experte

    vor 1 Woche

    Krems an der Donau, Niederösterreich, Österreich Quality Software & Consulting GmbH & CoKG Vollzeit

    AufgabenUnterstützung bei der Implementierung von Qualitätsmanagement-SystemenErstellung von Prozessdokumentationen und -konzeptenKoordination von Software-Tests und -ImplementierungenBetreuung von Kunden bei der Gestaltung von Qualitätsmanagement-ProzessenErarbeitung von Change-Requirements und Detailkonzepten für die...

  • Internist Oberarzt Innere Medizin: Een Uitdagende Carrière in de Interne Geneeskunde

    Vor 2 Tagen

    Krems an der Donau, Niederösterreich, Österreich BKV Vollzeit

    FunctiebeschrijvingBij BKV zoeken we een ervaren arts-specialist inwendige geneeskunde voor een functie als internist op Oberarzt niveau in een universitair ziekenhuis ten noordwesten van de stad Krems. De afdeling heeft een breed werkgebied en biedt de mogelijkheid om patiënten te behandelen in een setting die vergelijkbaar is met een intensive care...

  • System Engineer: Printing Solutions Specialist

    Vor 2 Tagen

    Krems an der Donau, Niederösterreich, Österreich Voestalpine Vollzeit

    About the JobWe are seeking a highly skilled System Engineer to join our team at Voestalpine. As a key member of our IT department, you will be responsible for designing, implementing, and maintaining our output management solutions.Key ResponsibilitiesCollaborate with our professional team to develop and improve our output management solutionsProvide 2nd...

  • Project Research Associate

    vor 10 Stunden

    Krems an der Donau, Niederösterreich, Österreich Universität für Weiterbildung Krems Vollzeit

    Job ResponsibilitiesConduct in-depth research in the field of historical textiles and bookbinding techniques, focusing on conservation methods and best practices.Develop and refine research charters, transitioning these into an electronic format for efficient data management.Manage and safeguard research data, contributing directly to ongoing conservation...

  • Validation and Qualification Engineer

    vor 4 Wochen

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job DescriptionOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every...

  • Prozessimplementierungs- und Support-Spezialist

    vor 3 Monaten

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job DescriptionDas erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur...

  • Produktionsmitarbeiter (m/w/d)

    vor 2 Monaten

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job DescriptionDas erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur...

  • Schichtleiter (m/w/d) - Filling & Visuelle Inspektion

    vor 4 Monaten

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job DescriptionDas erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur...

  • Associate Specialist Quality Assurance Systems

    vor 3 Monaten

    Krems an der Donau, Österreich MSD Vollzeit

    Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. Our...

  • Quality Assurance Specialist

    Vor 5 Tagen

    Bruck an der Leitha, Österreich Bunge Vollzeit

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Bunge. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and safety of our food products.Key ResponsibilitiesDevelop and implement quality assurance procedures to ensure compliance with regulatory requirements and company...

  • Senior Specialist Quality Assurance Systems

    vor 1 Monat

    Krems An Der Donau, Österreich MSD Vollzeit

    Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we...

  • Associate Specialist Quality Assurance Systems

    vor 2 Monaten

    Krems An Der Donau, Österreich MSD Vollzeit

    Job DescriptionOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every...

  • Software Quality Assurance Specialist

    Vor 5 Tagen

    Klaus an der Pyhrnbahn, Oberösterreich, Österreich OMICRON Vollzeit

    About OMICRONOMICRON is a leading provider of innovative solutions for the power supply industry. Our company is built on a strong foundation of employee satisfaction, which has earned us multiple awards in local and international 'Great Place to Work' rankings.We value trust, openness, and appreciation in our daily work, and have been guided by these...

  • Senior Specialist Qualification and Validation

    vor 3 Monaten

    Krems an der Donau, Österreich MSD Vollzeit

    Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. For our...

  • Software Quality Assurance Specialist

    Vor 5 Tagen

    Klaus an der Pyhrnbahn, Oberösterreich, Österreich OMICRON Vollzeit

    About OMICRONOMICRON is a leading provider of innovative solutions for the power supply industry. Our company is committed to delivering high-quality products and services that meet the evolving needs of our customers.Our TeamWe are a dynamic and agile team of developers and testers who are passionate about creating cutting-edge embedded devices. As a member...

  • Senior Specialist Bio Technology Solutions

    vor 3 Monaten

    Krems an der Donau, Österreich MSD Vollzeit

    Das erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur Aufgabe gemacht...

  • Senior Specialist Bio Technology Solutions

    vor 3 Monaten

    Krems an der Donau, Österreich MSD Vollzeit

    Das erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur Aufgabe gemacht...

  • Operational Technology Specialist

    vor 1 Woche

    Bruck an der Mur, Steiermark, Österreich PANKL RACING SYSTEMS AG Vollzeit

    Job DescriptionCompany OverviewPankl Racing Systems AG is a leading manufacturer of high-performance motor and drive systems for the racing, high-performance vehicle, and aerospace industries.We are seeking a highly skilled Operational Technology Specialist to join our team.Key ResponsibilitiesBetreuen, Dokumentation und Weiterentwicklung von OT...

  • Operational Technology Specialist

    vor 1 Woche

    Bruck an der Mur, Steiermark, Österreich PANKL RACING SYSTEMS AG Vollzeit

    Job DescriptionCompany OverviewPankl Racing Systems AG is a leading manufacturer of high-performance motor and drive systems for the racing, high-performance vehicle, and aerospace industries.We are seeking a highly skilled Operational Technology Specialist to join our team.ResponsibilitiesBetreuung, Dokumentation und Weiterentwicklung von OT...

  • Project Management Specialist

    vor 3 Monaten

    Krems an der Donau, Österreich MSD Vollzeit

    Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. Our...

  • Associate Specialist Quality Support

    vor 4 Wochen

    Krems An Der Donau, Österreich MSD Vollzeit

    Job DescriptionDas erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur...

  • Project Management Specialist

    vor 3 Monaten

    Krems an der Donau, Österreich MSD Vollzeit

    Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. Our...

  • Senior Specialist Qualification and Validation

    vor 3 Monaten

    Krems An Der Donau, Österreich MSD Vollzeit

    Job DescriptionOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every...

  • Quality Assurance Software Tester, Flexible Hours

    vor 2 Wochen

    Klaus an der Pyhrnbahn, Oberösterreich, Österreich OMICRON Vollzeit

    Company Overview: OMICRON electronics is at the forefront of developing and distributing cutting-edge solutions aimed at enhancing the safety and reliability of power supply systems. Our commitment to employee satisfaction has been recognized through numerous accolades in both local and international 'Great Place to Work' rankings. For over 35 years, we have...

  • Senior IT Infrastructure Specialist

    Vor 7 Tagen

    Spittal an der Drau, Kärnten, Österreich Remotivate LLC Vollzeit

    Our company, Remotivate LLC, is a leading provider of innovative solutions for the water and wastewater industry. We are committed to making a positive impact on the environment and are seeking a highly skilled Senior IT Infrastructure Specialist to join our team.Key Responsibilities As a Senior IT Infrastructure Specialist, you will be responsible for the...

  • Quality Assurance Software Tester, Flexible Hours

    vor 2 Wochen

    Klaus an der Pyhrnbahn, Oberösterreich, Österreich OMICRON Vollzeit

    Company Overview: OMICRON electronics is at the forefront of designing, developing, and distributing cutting-edge solutions aimed at enhancing the safety and reliability of power supply systems. Our commitment to employee satisfaction has been recognized through numerous accolades in both local and international 'Great Place to Work' rankings. We uphold...

  • Quality Assurance Software Tester, Flexible Hours

    vor 2 Wochen

    Klaus an der Pyhrnbahn, Oberösterreich, Österreich OMICRON Vollzeit

    Company OverviewOMICRON electronics is at the forefront of designing, developing, and distributing cutting-edge solutions aimed at enhancing the safety and reliability of power supply systems. Our commitment to employee satisfaction has been recognized through numerous accolades in both local and international 'Great Place to Work' rankings. We uphold values...

  • Specialist Bio Technology Solutions

    vor 3 Monaten

    Krems an der Donau, Österreich MSD Vollzeit

    **Job Description**: Das erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich...