2 days ago

QA Expert Release

962 BAXALTA BIOSCIENCE MFG SARL

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QA Expert Release

QA Expert Release
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products many of which are available in more than 100 countries across core therapeutic areas including Hematology Immunology Neuroscience Ophthalmics Lysosomal Storage Disorders Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema and a growing franchise in Oncology. Our employees come to work every day with a shared mission to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions and who lack effective therapies to live their lives to the fullest. We have an exciting new position within the Quality organization at the Neuchâtel facility here in Switzerland. This position will ensure the Quality oversight in the respective production area and 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 mindsetLiving our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following Leadership Behaviors Be PositiveBe AccountableBe Results OrientedBe An Excellent Manager of Self and Others

Pierre-à-Bôt 111 2000 Neuchâtel