Global Quality Audit Inspector - Switzerland
Want to know company name or location? Company managed [?]
- 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.
- 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.
- 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.
- 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
- 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