4 days ago

QA Expert Advate BDS

962 BAXALTA BIOSCIENCE MFG SARL

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QA Expert Advate BDS

QA Expert Advate BDS
Scope This position is within the Quality organization at the Neuchâtel facility and is intended for the Quality assurance department. The purpose of the job is to ensure the Quality oversight in the respective production area. The job holder has to support and improve GMP activities in a perspective of product release and site inspection readiness. The purpose of the job is to Be the Quality partner within Production Unit Team and oversee all the GMP activitiesParticipate to the Quality activities related to the batch record review from the raw material to the Final Product releaseExecute Shire guidelines and Regulatory cGMP requirements in the respective Quality areaExecute the implementation of facility projects in conformance to Shire and regulatory requirementsParticipate in GMP audits as requiredAct as Oversight Quality representative to ensure quality system and quality documentation in respect to current guidelines compliance and regulatory requirementsFor change control review and evaluate change requests according to processes methods quality systems and applicable regulatory files to meet Corporate Divisional and Regulatory requirements incl. IND BLA MAA files Assess results in terms of acceptability to standards procedures and regulatory requirementsProvide quality oversight in term of solving problems/root cause for deviation and CAPA.Ensure that all investigations and Change assessments are handled thoroughly consistently and in compliance with cGMP.Promote and be involved in Continuous Improvement for site Quality Requirements University degree in Engineering Biotechnology Pharmacy or Quality Management applied to industrial processAt least 5 years of experience in pharmaceutical and/or biotechnological companies.Fluent in French and English Specific skills required Good knowledge of FDA EMA ICH regulations Pharmacopeias and Quality system standardsKnowledgeable in auditing and inspection against regulatory/Quality standardsKnowledge/Experience with Quality tools such as TrackwiseGood analytical skills and ability to simplify the complexSolution oriented and team spiritGood listener and communication skillsGood organizational skills and continuous improvement mindset

Pierre-à-Bôt 111 2000 Neuchâtel