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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.

Qualifications
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                                       

Schedule
Full-time

Locations

Zurich Switzerland

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