GxP-Auditor (m/f/d) with excellent Italian or French skills + fluent in GER/EN
Entidade: CSL Plasma
Categoria de Vaga: Quality
Família de Vaga: Quality Assurance
Tipo de Vaga: Full Time
Location: Göttingen, Lower Saxony, Germany
Referência do Empregador: R-284014
Descrição da Vaga
CSL Plasma is one of the world's largest human plasma production companies for the manufacture of highly effective coagulation and immunoglobulin products.
For our Quality Assurance Department in Göttingen we are looking for a GxP-Auditor (m/f/d) with excellent language skills in EN/DE PLUS Italian OR French (full-time / permanent)
Your responsibilities:
Performance of qualification audits in the respective national language (EN/IT/FR/DE) in the EMEA region at plasma suppliers / service providers according to GxP and DIN ISO and evaluating the audit results
Performance of risk analyses and evaluation of the impact on the qualification status of the plasma supplier / service provider; evaluation of corrective / preventive measures
Review implementation and compliance with regulations and CSL quality requirements for all facilities to be audited
Assist in further development of the established audit systems
Assist in the creation and editing of standard operating procedures
Update various work lists to provide metrics up-to-date provision of key performance indicators
Electronic acquisition and processing of non-conformance reports
Participate in the implementation of trainings and workshops
Your profile:
Successfully completed vocational training or completed bachelor's degree in public health, natural sciences or similar area
2 - 3 years of professional experience as an auditor preferred but also career changers are welcome
Excellent language skills in Italian or French plus English and German (business fluent)
Willingness to travel intensively with a high degree of flexibility
Sound knowledge of quality management and GxP/DIN ISO area as well as audit/inspection experience preferable
Analytical and solution-oriented thinking skills as well as structured and independent working style
Ability to assess and interpret complex regulations
Ability to work in a team and to handle disputes as well as strong personal and social skills
Confident handling of MS Office standard software
Your Benefits:
Opportunities for personal and professional development e. g. further training as GxP-Auditor
A highly varying as well as demanding and responsible area of work
Pleasant working atmosphere in an international, dynamic, and high-performance team
Sobre a CSL Plasma
A CSL Plasma opera uma das maiores e mais sofisticadas redes de doação de plasma do mundo, com quase 330 centros de doação nos EUA e na Europa. A CSL Plasma é uma subsidiária da CSL, uma empresa biofarmacêutica global. O plasma coletado nas instalações da CSL Plasma é usado pela CSL com o único propósito de fabricar terapias derivadas de plasma que salvam vidas para pessoas em mais de 100 países. A empresa-mãe, CSL (ASX:CSL; USOTC:CSLLY), sediada em Melbourne, Austrália, emprega mais de 29.000 pessoas. Para mais informações sobre a CSL Plasma, visite https://www.cslplasma.com/.
Nossos Benefícios
Para mais informações sobre os benefícios da CSL Plasma, visite https://cslbenefits.com/cslp.
Você Pertence à CSL
Na CSL, Inclusão e Pertencimento estão no centro da nossa missão e de quem somos. Isso alimenta nossa inovação dia após dia. Ao celebrar nossas diferenças e criar uma cultura de curiosidade e empatia, somos capazes de entender e nos conectar melhor com nossos pacientes e doadores, fomentar relacionamentos fortes com nossos stakeholders e sustentar uma força de trabalho diversificada que levará nossa empresa e indústria para o futuro.
Para saber mais, visite https://www.csl.com/careers/inclusion-and-belonging
Empregador de Igualdade de Oportunidades
A CSL é um Empregador de Igualdade de Oportunidades. Se você é um indivíduo com deficiência e precisa de uma acomodação razoável para qualquer parte do processo de candidatura, visite https://www.csl.com/accessibility-statement.