QA ExpertApply Now Email Me Job ID SR0029642 Date posted 01/08/2019 Location:Neuchâtel, Switzerland
Takeda 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, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. In 2016, Takeda grew its organization to approximately 24,000 employees+ globally, following integrations of Dyax and Baxalta. An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 650 employees) for a Quality Assurance (QA) Expert position. This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Assurance teams within a world-class Biotech manufacturing environment. Job summary Within this position, QA Expert is responsible for Quality Assurance in the frame of activities all along the manufacturing and release processes. The QA Expert is the QA representative for both routine GMP activities and Takeda projects. He/She has to ensure quality of information within systems and documentation in respect to current guidelines, compliance and regulatory requirements. Participation in GMP audits will be part of activities. QA Expert shall promote and be involved in Continuous Improvement. Essential Duties and Responsibilities Participate to the Quality daily activities related to the batch record review and release. Participate to the Quality daily activities related to raw materials (release, specification implementation, etc...) Provide quality oversight in term of solving problems/root cause for deviations and CAPA. 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. Be a leader in the implementation of facility projects in conformance with regulatory requirements. Education & Experience University degree in Engineering, Biotechnology, Pharmacy, or Quality Management applied to industrial process or equivalent experience in pharmaceutical and /or biotechnological companies Good knowledge of Pharmacopeias standards and requirements Experience in Raw Material activities a plus Qualifications Knowledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality system standards Knowledgeable in auditing and inspection against regulatory / Quality standards Solution oriented and ability to simplify the complex Good listener, team oriented and good communication skills Good organization skills and continuous improvement mindset Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following: Be Positive Be Accountable Be Results Oriented Be An Excellent Manager of Self and Others
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