Chemistry Finished Product Quality Control Manager:

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Location
Montreal
Job Type
Permanent position
Category
Pharmaceutical/Biotechnology
Job number
090975
Scolarship
D.E.C.

Description

Chemistry Finished Product Quality Control Manager: Reporting to the Chemistry & Analytical Services Director, the QC Manager manages all activities related to testing of FDF (release and stability) by internal and external laboratories. QC testing is one of the key parts of the quality operations as it generates results allowing release or reject of products as well as ensuring the product on the market is compliant throughout its shelf life. The Manager has the responsibility to ensure the compliance to GLP (SOPs) requirements: i.e. lab investigation. Summary of tasks Provide Leadership to the QC supervisors by setting SMART objectives and achieving key performance and quality indicator targets for each subgroup. i.e. Zero Late Stability Testing, Release Cycle Time hit rate targets; Support and coach QC supervisors to effectively manage the personels in order to deliver the performance with quality laboratory work. Establish a process of capacity versus workload planning to ensure the on-time delivery to meet the compliance and site cycle time targets; To work within the QC supervisors, responsible for overseeing lab investigations (internal and external laboratories) in support of commercial drug manufacture; Drive the continuous improvement culture among the team members and apply LEAN techniques and effective training program; Evaluate, select and establish business relationship with key sub-contract lab partners Minimum requirements

Specific knowledge

Bachelor, Master or PhD degree in Chemistry or related field; Minimum of five (5) to eight (8) years' experience in a Management in GMP Quality Control laboratories in pharmaceutical or biotechnological industry; Excellent knowledge of GMP, (HPFB and FDA) and GLP; Good knowledge of the principles of HPLC/GC; Fluent French and English, both written and spoken, is essential;

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