Country Quality Specialist
Amgen Inc
Rotkreuz, ZG, CH
vor 1 Tg.

Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.

A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Every year, Amgen is included on numerous best employers’ lists worldwide, as we understand that our success rests on attracting and retaining the best talent.

Would you like to make an impact?

We are currently seeking a Country Quality Specialist for our International Quality team based in Rotkreuz, Switzerland.

This role will support the Swiss Responsible Person to coordinate and lead all aspects of GDP related operations for the wholesale, market release, import, export and foreign trade of medicinal products and to implement quality management systems and processes in accordance with local and international regulations and corporate company standards.

In this role you will act as deputy of the CH Responsible Person.

Additional responsibilities include :

  • Review of batch release documents to ensure that each batch of medicinal product has been manufactured and checked in compliance with the requirements of the Swiss marketing authorization
  • Support of all aspects related to in-country distribution and storage including evaluation of temperature data in collaboration with the logistics service provider for local batch acceptance and processing of product returns
  • Provide support to coordinate outsourced activities related to export and international trade including set-up and maintenance of quality agreements with distributors / wholesaler / local service providers
  • Processing of Product Quality Complaints (intake, report ability assessment and response to customers) and monthly monitoring of corresponding metrics and trends
  • Verification and approval of new customer and performance of periodic checks to ensure that customers are licensed to receive medicinal product
  • Qualification of external and internal suppliers including evaluation of GMP compliance of registered manufacturers
  • Maintain quality agreements with manufacturers, distributors, wholesalers and logistic service providers
  • Evaluation and / or processing of deviations, corrective and preventive actions and change controls in the corporate quality management tracking system
  • Compile periodic quality reports for management review
  • Preparation and support of authorities inspection, internal and external audits and annual self-inspections.
  • Write, review and approve procedures and / or job aids in compliance with corporate, site and regulatory requirements
  • Participate in the European International & Distribution Quality Team to ensure local input is provided and to support implementation activities at local and European level
  • Requirements :

  • You have a Master's Degree in Pharmacy or related life-sciences with the necessary experience
  • Ideally you acquire practical experience in Good Distribution Practice (GDP) and / or Good Manufacturing Practice (GMP) over at least 2 to 3 years
  • And in depth knowledge of GDP regulations pertinent to EU and other international markets is preferable.
  • You present proficiency at a business level in English and German language. French knowledge is a plus.
  • Effective and professional communication skills at multiple levels and areas (inside and outside of Quality) in English and German
  • You are able to work globally in a matrix environment
  • You show attention to detail with a hand on approach to problem solving
  • And excellent analytical skills and ability to apply risk-based approach based on science, data and understanding of regulatory requirements.
  • As well as team based work ethic
  • Are you keen on helping to improve patients' lives?

    Does this sound like the perfect next step in your career?

    If you answer both questions with yes, please submit your application online.

    We understand that to successfully sustain and grow as a global enterprise and deliver for patients we ensure a diverse and inclusive work environment.

    Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status,

    or disability status.

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