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Global Quality Audit Inspector Zürich Switzerland,  

Takeda (company)

Posted on : 26 January 2017

Project Description

About Us:
  •  We are a truly global partner for better health. 
  • Our company  is dedicated to pharmaceutical innovation and tackling diseases for which there is currently no cure. 
  • We are expanding continuously into new fields of treatment and therapy. 
  • By always putting people first, we empower employees so everyone can develop to his or her full potential. 
  • We are looking for colleagues with the right skills and experiences to support us in improving the quality of the most precious thing we know: life
  • We are looking for a strong candidate for the position of Global Quality Audit Inspector. 

Job Description:
  • As a member of the Global Quality Auditing group you will focus on the following areas:
    • Provide global Quality governance via routine audit processes and Due Diligence activities. 
    • The scope will include both internal or external inspections based on business needs
    • Participate in management and preparation of the inspections as required to support business development and other GQA activities
    • Provide Quality support and advice to support business development projects
    • Provide leadership in driving continuous improvement of inspection readiness activities across the global network
    • Deliver timely outcomes in execution of compliance improvement projects as assigned 
    • Participate/ support Global Quality initiatives in alignment with the vision, annual goals and assistance as assigned.

You will be responsible for: 
  • Support Due Diligence activities worldwide in conjunction with Head of Global Quality Audit Due Diligence. 
  • This will include both inspection and acting as quality SME in support of the assigned Business Development project.
  • Provide quality support and advice to support business development projects.
  •  Function as a full partner for business development by identifying quality related risks to projects and the provision of appropriate resolutions.
  • Participate in internal and external audits in accordance with the approved GQA audit schedule as required
  • Ensure all audits and inspections are executed in accordance with company procedures and reported on within agreed format and  timelines
  • Promptly escalate and report all critical audit findings to the Global Quality Audit Region Head in accordance with Global Audit policies and procedures.
  • Participate in preparation and maintenance of global audit policies, guidance, standards, and procedures  
  • Ensure personal training is completed on time for all global quality policies, standards and procedures
  • Participate in inspection preparation activities at sites prior to significant inspections as required, including inspector profiling and 483 and EIR trend review
  • Participate in training activities across the Global Quality network to ensure technical and compliance knowledge stays current with industry and regulatory trends
  • Be a role model for the company  and provide positive representation of company  when dealing with external partners
  • Engage and support appropriate projects such as Inspector Reviews, FDA 483 reviews as required
  • Partner with Quality functions such as Global Compliance to understand points of emphasis during upcoming audits such as Quality Systems performance and alignment on Quality Culture.

What you should bring:
  • Bachelor s Degree in Pharmacy, Science or Engineering or equivalent combination of education and experience.  Masters Degree a plus.
  • Minimum of 10 years professional working experience in pharmaceutical manufacturing, Quality Control, Quality Assurance or related compliance experience with at least 2 years executing audits for GMP / GDP, ISO and ICH..
  • Qualified as an auditor by an organization recognized within the pharmaceutical industry or equivalent. 
  • Strong knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in US, Europe and Japan. 
  • Ability to develop knowledge of regulations in other markets as required. 
  • Working knowledge of a pharmaceutical manufacturing technologies used for a variety of pharmaceutical formulation types
    • API manufacturing
    • Solid dose
    • Liquid, suspensions, suppositories, pastes
    • Sterile products  aseptic process and terminal sterilization
    • Biological processes for large molecule products
    • Vaccines
  • Strong knowledge of Pharmaceutical Laboratories, technologies, systems and processes.
  • Ability to influence and work effectively across various regions and cultures.
  • Strong interpersonal skills including listening, judgment, conflict management, ability to lead teams in a global environment.
  • Ability to anticipate potential problems and risks related to quality system / regulatory expectations including ability to formulate and implement solutions.
  • Demonstrated teamwork, initiative and problem solving skills.
  • Strong oral/written communication skills appropriate for diverse international collaboration including excellent fluency in English and regional languages as needed.
  • Effective collaborator across functions to achieve positive outcomes
  • Ability and willingness to travel approximately 50% of the time
  • All applicants must hold a Swiss Work Permit or an EU Passport                                       



Zurich Switzerland

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