Quality Control Manager

NyonFixeChimie, Pharma, Biotechnologie2019-03-27Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Quality Control Manager


• Lead the Immunohematology/serology, biochemistry and Microbiology function
• Manage, plan and coordinate the activities 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 escalated 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


• Biochemistry, hematology or microbiology degree (Pharmaceutical/Biotechnologies...)
• Experience in blood 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 manage 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

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