3 days ago

QA Expert - Fill Finish/Warehouse/Utilities

962 BAXALTA BIOSCIENCE MFG SARL

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QA Expert - Fill Finish/Warehouse/Utilities

QA Expert Fill Finish/Warehouse/Utilities
QA Expert For Fill Finish/Warehouse/Utilities Job Summary This position is within the Quality organization at the Neuchâtel facility and is intended for the Quality assurance department. Within this position you will be responsible for Quality Assurance in the frame of activities all along the manufacturing and release process. You will be QA representative for both routine GMP activities and Shire projects. Participation in GMP audits will be part of your activities . The position will also give you the opportunity to bring some new propositions and ideas in the frame of the continuous improvement. The purpose of the job is to Be the Quality partner within Production Unit Team and oversee all the GMP activities Be a leader in the implementation of facility projects in conformance with regulatory requirements For 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 Provide quality oversight in term of solving problems/root cause for deviation and CAPA Promote and be involved in Continuous Improvement Be involved in preparation and presentation during GMP audits Ensure quality system and quality documentation in respect to current guidelines compliance and regulatory requirements Assess results in terms of acceptability to standards procedures and regulatory requirement Participate to the Quality activities related to the batch record review 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 Living 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 About Us 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.

Pierre-à-Bôt 111 2000 Neuchâtel