Quality Assurance Specialist (m/f/d)

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Our Human Health Division maintains a "patient first, profits later" ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.

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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are continually striving to improve the understanding of health care within the local community. Our site in 1220 Vienna is a strategic location for the distribution of our high quality and innovative health care products, as well as digitally integrated solutions for our patients and clients. To ensure sustainable company growth, we continually aim to offer attractive career opportunities for our employees at our Vienna site. In support of our existing team we are currently looking for the position of:

Quality Assurance Specialist (m/f/d)

Temporary position limited for 1 year with the possibility of extension

Responsibilities

  • Ensure that regulations relating to Quality and Compliance for distribution and wholesaling of products on the markets (GDP) are fulfilled
  • Local contact to Health Authority, local business and regional Quality Management interactions and notifications regarding Quality issues
  • Develop, implement and maintain the local Quality Management System
  • Maintaining the Document Management System
  • Apply principles of Quality Risk Management
  • Maintaining the local training system and carry out GxP employee trainings
  • Handling of Product Quality complaints and suspected Counterfeit, Diversion or Tampering cases including Health Authority notifications
  • Assessment of temperature excursions
  • Customer and Supplier Qualification
  • Management and documentation of tasks with GxP impact
  • Change Control Management
  • Deviation handling (incl. definition and follow-up of CAPAs)
  • Notification to Health Authority of the intention to market vaccines (Marketing Information Form)
  • Management Review and Quality Metrics
  • (Self-)Inspections, Audits and Due Diligence visits
  • Close collaboration with Distribution & Logistics and the third-party logistics provider

Qualifications & Experience

  • Higher education (e.g. Masters degree strongly preferred) in pharmacy, medicine, biology or a comparable discipline
  • Experience in Quality Assurance (GMP/GDP) within pharmaceutical industry and with local Austrian, European and international GxP regulations would be an asset, however position is also suitable for recent graduates
  • Excellent analytical and problem-solving skills, based on science, data and understanding of regulatory requirements in a complex and evolving environment; ability to apply sound risk management
  • Excellent communication and prioritization abilities
  • Fluency in German and English

This position is limited to a term of 1 year with the possibility of extension. MSD offers 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 38.400,-- and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Apply online

Merck Sharp & Dohme GesmbH, ARES TOWER, Donau-City-Straße 11, A-1220 Wien, www.msd.at

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