NonStop Recruitment

QA External Manuf-Intl Biotech-Switzerland

My client is a successful and one of the oldest biotech company, and they are currently recruiting a QA Specialist with 3rd party manufacturers, to take the position in Zug, Switzerland


You will collaborate with their business partners to proactively develop best compliance practices to regulatory expectations, excellence in technical approaches, and continuous improvement to build efficiency and flexibility in their quality systems.


The company offers long-term career perspective, and a high recognition and experience that will be a really strong asset to reach your professional objectives.

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This is an outstanding opportunity if you would like to make most of your expert knowledge in Quality Assurance.


Responsibilities:



  • Assure the timely and appropriate close out of deviations and investigations involving partners and contractors

  • Manage the QA interface with manufacturing and testing partners for clinical and commercial product, ensure quality issues are tracked and resolved in a timely manner

  • Provide technical support for the manufacture of product at Contract Manufacturer Organizations (CMOs).

    Ensure that the CMOs maintain quality systems that are in the state of compliance

  • Prepare/ manage quality agreement with manufacturing and testing partner for commercial product

  • Participate in regulatory inspections and support regulatory inspections at CMOs.

    Perform risk assessments as preventive measures or in response to product/ quality system failures, investigations and regulatory inspections

  • Coordinate of preparation and review of domestic and international regulatory filings

  • Performs other duties as required to support department, functional and company goals


Qualifications:



  • A minimum of 3 years of experience in similar position in pharmaceutical or biotechnology industries

  • Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies' regulations is a plus)

  • Relevant experience in either manufacturing, development, quality, or regulatory

  • Positive and pragmatic attitude with focus on delivery on time

  • Strong team player and have excellent communication skills (verbal and written) in English


Education:



  • BS in Biochemistry, Microbiology, Chemical/Biochemical Engineering or related discipline


Call me, Arnaud Schmitt-Fillaire, at NonStop Recruitment now for a confidential conversation at +41 43 508 08 17 and please send your CV (ideally in MS Word format) at: a.schmitt-fillaire@nonstop-pharma.ch


OR if this does not sound like the opportunity for you, but you are a professional within the Pharmaceutical industry, please feel free to get in touch, to see other opportunities we may have within this field.


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NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe.

We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry.

Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe.

Please visit our website for a full list of the niche markets we cover.


NonStop ist eine der schnellsten wachsenden Personalagenturen mit Spezialisierung auf Pharma und Medizintechnik in Europa.

Wir sind ein stolzes Mitglied von APSCo, was sicherstellt, dass wir die höchsten Qualitätsstandards in der Personalvermittlungsbranche garantieren.

Wir sind durch Büros in Großbritannien, in der Schweiz und Tschechien vertreten, weitere Büros in Berlin und Barcelona sind in Planung.

Wir haben Arbeitnehmerüberlassungsgenehmigungen für verschiedene europäische Länder.

Auf unserer Homepage können Sie mehr über die Nischenmärkte erfahren, in denen wir tätig sind.




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