Associate Specialist Quality Assurance Systems

vor 1 Woche

Krems an der Donau, Niederösterreich, 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 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 create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

For our site in Krems, we are currently looking for an:

Associate Specialist Quality Assurance Systems (M/F/d)
- (Fixed term for 2 years, Full-time)_


The Associate Specialist Quality Assurance Systems will be responsible for the quality aspects of key Quality systems with a focus but not limited to GMP computerized systems and supporting infrastructure to ensure compliance with company policies, procedures and regulatory expectations.


The Associate Specialist must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.


Main Responsibilities:

  • Support/drive maintenance and improvement of established Quality Systems
  • Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and Company IT Owner)
  • Providing the independent quality approval of key qualification and validation documentation to ensure compliance to company standards and applicable regulations
  • Providing the independent quality review and approval of changes / deviations / compliance investigations, CAPA.
  • Supporting regulatory inspection and audit activities.
  • Driving resolution of regulatory nonconformance.
  • Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
  • Promoting GMP awareness and a culture of continuous improvement and supporting manufacturing process improvements, laboratory operational excellence and validation activities.

Requirements:

  • Bachelor's degree or other equivalent education, preferably in Engineering, Biotechnology or relevant experience
  • Experience in a regulated pharmaceutical manufacturing and/or laboratory environment, Quality or Compliance role in GMP environment desired (FDA/EU/ICH)
  • Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory or biotechnology manufacturing environment
  • Operate as part of a selfdirected team in carrying out day to day functions and assigning priorities
  • Excellent oral and written communication skills including developing cross functional relationships
  • Analytical problemsolving skills to issue identification and resolution
  • Fluency in written and spoken German and English


We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment.

The minimum annual salary for this position is EUR 44.100;

Search Firm Representatives Please Read Carefully

Employee Status:

Project Temps (Fixed Term)

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID:
R287636

  • Associate Specialist Quality Assurance Systems

    vor 1 Monat

    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...

  • Associate Specialist Quality Assurance Systems

    vor 1 Woche

    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...

  • Associate Specialist Quality Assurance Systems

    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...

  • Specialist Quality Assurance Systems

    Vor 4 Tagen

    Krems an der Donau, Niederösterreich, 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 Operations

    vor 1 Woche

    Krems an der Donau, Niederösterreich, 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 zur...

  • Senior Quality Specialist

    vor 1 Woche

    Krems an der Donau, Niederösterreich, 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...

  • Quality Project Specialist

    vor 2 Wochen

    Krems an der Donau, Niederösterreich, 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 Quality Specialist

    vor 1 Woche

    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...

  • Senior Quality Specialist

    vor 2 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...

  • Site Quality Head

    vor 2 Wochen

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job Description: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...

  • Associate Director Aseptic Process Support

    vor 1 Woche

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job Description: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...

  • Spezialist für Qualitätsprojekte

    vor 1 Monat

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job DescriptionThe main goal of our Production & Delivery department is to act as the most reliable manufacturer and supplier of biopharmaceuticals worldwide. We operate a global production network in close collaboration with our internal production facilities, external contractors, suppliers, and partners to deliver high-quality products to customers and...

  • Spezialist für Qualitätsprojekte

    vor 4 Wochen

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job DescriptionThe main goal of our Production & Delivery department is to act as the most reliable manufacturer and supplier of biopharmaceuticals worldwide. We operate a global production network in close collaboration with our internal production facilities, external contractors, suppliers, and partners to deliver high-quality products to customers and...

  • Spezialist für Qualitätsprojekte

    vor 2 Wochen

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job DescriptionThe main goal of our Production & Delivery department is to act as the most reliable manufacturer and supplier of biopharmaceuticals worldwide. We operate a global production network in close collaboration with our internal production facilities, external contractors, suppliers, and partners to deliver high-quality products to customers and...

  • Project Management Specialist

    vor 2 Wochen

    Krems an der Donau, Niederösterreich, 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...

  • Project Management Specialist

    vor 1 Woche

    Krems an der Donau, Niederösterreich, 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 1 Woche

    Krems an der Donau, Niederösterreich, 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...

  • Senior Specialist Qualification and Validation

    Vor 5 Tagen

    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...

  • Continuous Improvement and Projects Specialist

    vor 1 Woche

    Krems an der Donau, Niederösterreich, 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...

  • Specialist Supply Chain Management Customer Service

    vor 2 Wochen

    Krems an der Donau, Niederösterreich, Österreich MSD Vollzeit

    Job Description: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...