von Heute

Quality Control Manager

Quotient

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Quality Control Manager

Qu otient is a commercial - stage diagnostics company committed to increasing efficiencies and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and donor disease screening (transfusion diagnostics), Quotient is developing MosaiQ™, its next generation automation p latform to address the comprehensive needs of the global transfusion diagnostics market. Once approved for sale, MosaiQ™ will be the first fully automated solution for blood grouping, quickly and comprehensively characterizing both donor and patient blood, improving patient outcomes and eliminating the need for expensive and time - consuming manual testing. MosaiQ™ will also undertake all mandated serological disease screening tests required for donor blood. Quotient has over 30 years of experience developing , manufacturing and commercializing transfusion diagnostic products The company's operations are based in Switzerland, Scotland and the US We are now recruiting for our next: Quality Control Manager Your main responsibilities as a QC Manager will be to ensure that all testing is carried out in accordan ce with GMP. This should be achieved by developing a comprehensive approach to Quality Control applicable to all of Quotient Suisse 's activities ? Lead the Immunohematology/serology, biochemistry and Microbiology function ? Manage, plan and coordinate the act ivities of the Quality Control Department Laboratories to ensure analytical requirements are met ? Ensure that testing is carried out in a timely manner to support manufacturing and meet delivery requirements ? Manage and report OOS ensuring that events are es calated in a manner reflecting the degree of severity ? Investigate product performance customer complaints ? Provide analytical input to the development of new products to ensure analytical requirements are appropriate . ? Ensure analytical procedures and practices meet the requirements of the EC IVD Directive, FDA standards, GMP, ISO 9001/EN46001 and Health & Safety Policies ? Manage and lead the training and appraisal of staff within the Quality Control Department, in order ensure continuous development of staff ? Contribute to the design and implementation of new quality systems and procedures and identify areas for potential improvement to ensure the concept of continuous quality improvement is realised ? B iochemistry, hematology or microbiology degree (Pharmaceutical/Biotechnologies) ? Experience in blood Qual group serology is essential plus laboratory experience in a GMP environment ? Min. 5 years at management level in a Manufacturing/Quality position ? Experience working with and interacting with Notified Bodies and Competent Authorities ? Knowledge of GMP and compliance as applied to the manufacture of diagnostic devices ? Strong leadership skills to man age a team, team player and effective communication with a wide range of international customers, regulatory authorities at all organisational levels ? Proficient in English and French ? Ability to travel up to 10% of the time

Route de Crassier 13 Terre Bonne Park Bâtiment B 1 1262 Eysins