Quality Control Manager
Quality Control Manager
Spring Life Sciences is looking for his client a
Quality Control Manager
Responsibilities:
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
Profile:
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
Votre contact
Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.
geneva.lifesciences@springprofessional.ch
Merci de préciser la référence HAID
BewerbenText
Quality Control Manager
Responsibilities:
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
Profile:
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
Votre contact
Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.
geneva.lifesciences@springprofessional.ch
Merci de préciser la référence HAID
BewerbenText
